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Product Recall Tracker

SunMed Holdings, LLC Recall 93237

Page Last Updated: July 26, 2024

Description: Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6, AF5140MB-F, AF1140MB-T, AF1140MB-PW, AF5140MB-PW, AF1140MB-I, AF5140MB-I, AF5140MBN, AF1140MBS, AF5140MBS, AF1140MB-X, AF5140MB-X, AF1140MB-P, AF5140MBP, AF1140MB-K, AF5140MBS-I,AF5140MBPF-G10, AF5140MBP-G10, AF1140MBP-T, AF5140MBP-I, AF1140MBP-K, AF1140MBC-N, AF1140MBP-2, AF1140MC, AF5140MC, AF1140MCP, AF5140MC-P, AF1100MB, AF5100MB, AF5100MC, AF1140MC-M5, AF1140MB-TM5, AF1140MBP-TM5, AF1100MC, AF1140OB, AF1140MBP-M5, AFW1140MB,AF1140MBS-P, AF1000MBN-20, AF5102MBP, AF1100MB-N, AF1100MC-P, AF1140MB, AF1140MB-E, AF1140MB-N, AF1140MB-R, AF1140MBS-K, AF1140MBSP-I, AF1142MB, AF1100MBS, AF1100MB-MMC, AF1100MB-PWG1, AF1100MBP; 2. AirFlow Child Resuscitator REF #s: AF4100MCP, AF4140MB, AF4140MB-I, AF4140MBP, AF4140MB-PI, AF4100MB, AF4100MBP, AF4100OB, AF4140MB-D23, AF4140OBP, AF4140MCP-D3, AF4140MC; 3. AirFlow Infant Resuscitator REF #s: AF3140OB, AF3144MB, AF3104MB-PW, AF3100MBP- M0D1, AF3100MBP- M012, AF3140MB-M000, AF3140MB-D2, AF3140MB-D1, AF3140MB-S1, AF3140MB-2B, AF3140MB-I, AF3140MB-K, AF3100MB-PW, AF3100MB-PTS1, AF3100MB-M0- D1, AF3100OC, AF3100MC-2, AF3100MC, AF3106MC-2, AF3140MCP-K, AF3140MC-2B, AF3100MCP-2, AF3140MC- M0D12, AF3144MCP- M1M00, AF3100OB, AF3140MB, AF3140MB-M0, AF3140MB-2, AF3140MB-M1, AF3140MB-PW, AF3140MB-P, AF3140MB-D12I, AF3140MBP-2, AF3140MC, AF3140MCP, AF3140MCPF, AF3100MB, AF3100MB-M0, AF3100MB-2, AF3100MB-M1, AF3100MB-X, AF3100MBP, AF3100MB-M01, AF3100MBP-M01, AF3100MBP-2, AF3100MBP-D12, AF3100MCP; 4. AirFlow Pediatric Resuscitator REF #s: AF2100OB, AF2100MB-3, AF2102OB, AF2100MB-D5, AF2140OB, AF2102MBP-2, AF2102MBPW-D4, AF2102MBP-M3, AF2140MB-2, AFW2142OB, AF2140MB-D4, AF2140MB-D43, AF2140MB-P2, AF2144MB, AFW2142MB-2, AF2142MB-D3, AF2242MBP, AF2142MBS-I, AF2142MBP- 224OT, AF2140MBPW- D23, AF2140MB-I, AF2140MB-K, AF2140MB-S, AF2140MBP-K, AF2100MB-PW, AF2100MB-MMC, AF2102MBP, AF2100MB- PWTS4, AF2140MCPF, AF2100MC, AF2102MC, AF2142MC-M01, AF2140MC, AF2142MC-D34, AF2140MCP-D4, AF2140MC-PT, AF2140MCP-K, AF2142MCP, AF2100MCP, AF2102MB, AF2102MCP, AF2102MC-PT, AF2142OB, AF2142OBNS, AF2142MB, AF2142MB-3, AF2142MB-2, AF2142MB-M5E, AF2142MB-PW, AF2142MBP, AF2142MB-K, AF2142MBP-2, AF2142MC-3, AF2142MCP-D4, AF2140MB, AF2140MB-PW, AF2140MBP, AF1142OB, AF2100MB; 5. AirFlow Small Adult Resuscitator REF #s: AF5140MC-D6, AF5140MB-M5, AF5100MB-D5, AF5142MBP-M5, AF5140MBPW-D5, AF5140MBPWTD5, AF5140MBP-D5, AF5140MBP-D6, AF5140MBPW- M5, AF5140MBP-M5, AFN5140MB, AF5140MB-OT, AF5140MB-T, AFD5140MB-T, AF5140MB-K, AF5140MBS-R, AF5140MBS-P, AF5140MB-PT, AF5140MB-ST, AF5140MCP-K, AF5100MB-PW, AF5102MB-N, AF5140MBS-M5. 6. Ventlab, LLC Resuscitation Kit REF # MC1000.

SunMed Holdings, LLC Recall 93237 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0361-2024
Event ID93237
Event DescriptionVentlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6, AF5140MB-F, AF1140MB-T, AF1140MB-PW, AF5140MB-PW, AF1140MB-I, AF5140MB-I, AF5140MBN, AF1140MBS, AF5140MBS, AF1140MB-X, AF5140MB-X, AF1140MB-P, AF5140MBP, AF1140MB-K, AF5140MBS-I,AF5140MBPF-G10, AF5140MBP-G10, AF1140MBP-T, AF5140MBP-I, AF1140MBP-K, AF1140MBC-N, AF1140MBP-2, AF1140MC, AF5140MC, AF1140MCP, AF5140MC-P, AF1100MB, AF5100MB, AF5100MC, AF1140MC-M5, AF1140MB-TM5, AF1140MBP-TM5, AF1100MC, AF1140OB, AF1140MBP-M5, AFW1140MB,AF1140MBS-P, AF1000MBN-20, AF5102MBP, AF1100MB-N, AF1100MC-P, AF1140MB, AF1140MB-E, AF1140MB-N, AF1140MB-R, AF1140MBS-K, AF1140MBSP-I, AF1142MB, AF1100MBS, AF1100MB-MMC, AF1100MB-PWG1, AF1100MBP; 2. AirFlow Child Resuscitator REF #s: AF4100MCP, AF4140MB, AF4140MB-I, AF4140MBP, AF4140MB-PI, AF4100MB, AF4100MBP, AF4100OB, AF4140MB-D23, AF4140OBP, AF4140MCP-D3, AF4140MC; 3. AirFlow Infant Resuscitator REF #s: AF3140OB, AF3144MB, AF3104MB-PW, AF3100MBP- M0D1, AF3100MBP- M012, AF3140MB-M000, AF3140MB-D2, AF3140MB-D1, AF3140MB-S1, AF3140MB-2B, AF3140MB-I, AF3140MB-K, AF3100MB-PW, AF3100MB-PTS1, AF3100MB-M0- D1, AF3100OC, AF3100MC-2, AF3100MC, AF3106MC-2, AF3140MCP-K, AF3140MC-2B, AF3100MCP-2, AF3140MC- M0D12, AF3144MCP- M1M00, AF3100OB, AF3140MB, AF3140MB-M0, AF3140MB-2, AF3140MB-M1, AF3140MB-PW, AF3140MB-P, AF3140MB-D12I, AF3140MBP-2, AF3140MC, AF3140MCP, AF3140MCPF, AF3100MB, AF3100MB-M0, AF3100MB-2, AF3100MB-M1, AF3100MB-X, AF3100MBP, AF3100MB-M01, AF3100MBP-M01, AF3100MBP-2, AF3100MBP-D12, AF3100MCP; 4. AirFlow Pediatric Resuscitator REF #s: AF2100OB, AF2100MB-3, AF2102OB, AF2100MB-D5, AF2140OB, AF2102MBP-2, AF2102MBPW-D4, AF2102MBP-M3, AF2140MB-2, AFW2142OB, AF2140MB-D4, AF2140MB-D43, AF2140MB-P2, AF2144MB, AFW2142MB-2, AF2142MB-D3, AF2242MBP, AF2142MBS-I, AF2142MBP- 224OT, AF2140MBPW- D23, AF2140MB-I, AF2140MB-K, AF2140MB-S, AF2140MBP-K, AF2100MB-PW, AF2100MB-MMC, AF2102MBP, AF2100MB- PWTS4, AF2140MCPF, AF2100MC, AF2102MC, AF2142MC-M01, AF2140MC, AF2142MC-D34, AF2140MCP-D4, AF2140MC-PT, AF2140MCP-K, AF2142MCP, AF2100MCP, AF2102MB, AF2102MCP, AF2102MC-PT, AF2142OB, AF2142OBNS, AF2142MB, AF2142MB-3, AF2142MB-2, AF2142MB-M5E, AF2142MB-PW, AF2142MBP, AF2142MB-K, AF2142MBP-2, AF2142MC-3, AF2142MCP-D4, AF2140MB, AF2140MB-PW, AF2140MBP, AF1142OB, AF2100MB; 5. AirFlow Small Adult Resuscitator REF #s: AF5140MC-D6, AF5140MB-M5, AF5100MB-D5, AF5142MBP-M5, AF5140MBPW-D5, AF5140MBPWTD5, AF5140MBP-D5, AF5140MBP-D6, AF5140MBPW- M5, AF5140MBP-M5, AFN5140MB, AF5140MB-OT, AF5140MB-T, AFD5140MB-T, AF5140MB-K, AF5140MBS-R, AF5140MBS-P, AF5140MB-PT, AF5140MB-ST, AF5140MCP-K, AF5100MB-PW, AF5102MB-N, AF5140MBS-M5. 6. Ventlab, LLC Resuscitation Kit REF # MC1000.
Product TypeDevices
DistributionUS Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.
QuantityN/A
Recall ReasonA backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Device Classification20231129
Device Code InfoUDI-DI: 10889483075814 (Item # AF1000MBN-20, Case UDI: 30889483075818); UDI-DI: 10889483076606 (Item # AF1100MB, Case UDI: 30889483076600); UDI-DI: 10889483076613 (Item # AF1100MB-MMC, Case UDI: 30889483076617); UDI-DI: 10889483075838 (Item # AF1100MB-N, Case UDI: 30889483075832); UDI-DI: 10889483088074 (Item # AF1100MBP, Case UDI: 30889483088078); UDI-DI: 10889483086209 (Item # AF1100MB-PWG1, Case UDI: 30889483086203); UDI-DI: 10889483086216 (Item # AF1100MBS, Case UDI: 30889483086210); UDI-DI: 10889483094365 (Item # AF1100MC, Case UDI: 30889483094369); UDI-DI: 10889483159217 (Item # AF1100MC-P, Case UDI: 30889483159211); UDI-DI: 10889483071809 (Item # AF1140MB, Case UDI: 30889483071803); UDI-DI: 10889483230626 (Item # AF1140MBC-N Case UDI: 30889483230620); UDI-DI: 10889483090718 (Item # AF1140MB-D5, Case UDI: 30889483090712); UDI-DI: 10889483106372 (Item # AF1140MB-E, Case UDI: 30889483106376); UDI-DI: 10889483095096 (Item # AF1140MB-I, Case UDI: 30889483095090); UDI-DI: 10889483083918 (Item # AF1140MB-K, Case UDI: 30889483083912); UDI-DI: 10889483162224 (Item # AF1140MB-M5, Case UDI: 30889483162228); UDI-DI: 10889483094372 (Item # AF1140MB-N, Case UDI: 30889483094376); UDI-DI: 10889483098370 (Item # AF1140MB-P, Case UDI: 30889483098374); UDI-DI: 10889483101469 (Item # AF1140MBP-2, Case UDI: 30889483101463); UDI-DI: 10889483106396 (Item # AF1140MBP-K, Case UDI: 30889483106390); UDI-DI: 10889483076637 (Item # AF1140MBP-M5, Case UDI: 30889483076631); UDI-DI: 10889483078143 (Item # AF1140MBP-T, Case UDI: 30889483078147); UDI-DI: 10889483162637 (Item # AF1140MBP-TM5, Case UDI: 30889483162631); UDI-DI: 10889483098387 (Item # AF1140MB-PW, Case UDI: 30889483098381); UDI-DI: 10889483074190 (Item # AF1140MB-R, Case UDI: 30889483074194); UDI-DI: 10889483095119 (Item # AF1140MBS, Case UDI: 30889483095113); UDI-DI: 10889483093320 (Item # AF1140MBS-K, Case UDI: 30889483093324); UDI-DI: 10889483076422 (Item # AF1140MBS-P, Case UDI: 30889483076426); UDI-DI: 10889483089088 (Item # AF1140MBSP-I, Case UDI: 30889483089082); UDI-DI: 10889483087213 (Item # AF1140MB-T, Case UDI: 30889483087217); UDI-DI: 10889483162439 (Item # AF1140MB-TM5, Case UDI: 30889483162433); UDI-DI: 10889483227589 (Item # AF1140MB-X, Case UDI: 30889483227583); UDI-DI: 10889483101476 (Item # AF1140MC, Case UDI: 30889483101470); UDI-DI: 10889483163146 (Item # AF1140MC-M5, Case UDI: 30889483163140); UDI-DI: 10889483097359 (Item # AF1140MCP, Case UDI: 30889483097353); UDI-DI: 10889483102121 (Item # AF1140OB, Case UDI: 30889483102125); UDI-DI: 10889483078150 (Item # AF1142MB, Case UDI: 30889483078154); UDI-DI: 10889483089255 (Item # AF1142MBP, Case UDI: 30889483089259); UDI-DI: 10889483089095 (Item # AF1142OB, Case UDI: 30889483089099); UDI-DI: 10889483096390 (Item # AF2100MB, Case UDI: 30889483096394); UDI-DI: 10889483076019 (Item # AF2100MB-3, Case UDI: 30889483076013); UDI-DI: 10889483171578 (Item # AF2100MB-D5, Case UDI: 30889483171572); UDI-DI: 10889483078181 (Item # AF2100MB-MMC, Case UDI: 30889483078185); UDI-DI: 10889483159231 (Item # AF2100MB-PW, Case UDI: 30889483159235); UDI-DI: 10889483102138 (Item # AF2100MB- PWTS4, Case UDI: 30889483102132); UDI-DI: 10889483090749 (Item # AF2100MC, Case UDI: 30889483090743); UDI-DI: 10889483101506 (Item # AF2100MCP, Case UDI: 30889483101500); UDI-DI: 10889483095706 (Item # AF2100OB, Case UDI: 30889483095700); UDI-DI: 10889483098394 (Item # AF2102MB, Case UDI: 30889483098398); UDI-DI: 10889483112977 (Item # AF2102MBP, Case UDI: 30889483112971); UDI-DI: 10889483076644 (Item # AF2102MBP-2, Case UDI: 30889483076648); UDI-DI: 10889483097304 (Item # AF2102MBP-M3, Case UDI: 30889483097308); UDI-DI: 10889483172285 (Item # AF2102MBPW-D4, Case UDI: 30889483172289); UDI-DI: 10889483158883 (Item # AF2102MC, Case UDI: 30889483158887); UDI-DI: 10889483078198 (Item # AF2102MCP, Case UDI: 30889483078192); UDI-DI: 10889483085769 (Item # AF2102MC-PT, Case UDI: 30889483085763); UDI-DI: 10889483077924 (Item # AF2102OB, Case UDI: 20889483077921); UDI-DI: 10889483078068 (Item # AF2140MB, Case UDI: 30889483078062); UDI-DI: 10889483081143 (Item # AF2140MB-2, Case UDI: 30889483081147); UDI-DI: 10889483076286 (Item # AF2140MB-D4, Case UDI: 30889483076280); UDI-DI: 10889483112984 (Item # AF2140MB-D43, Case UDI: 30889483112988); UDI-DI: 10889483077566 (Item # AF2140MB-I, Case UDI: 20889483077563); UDI-DI: 10889483081150 (Item # AF2140MB-K, Case UDI: 20889483081157); UDI-DI: 10889483088111 (Item # AF2140MBP, Case UDI: 30889483088115); UDI-DI: 10889483096413 (Item # AF2140MB-P2, Case UDI: 30889483096417); UDI-DI: 10889483083734 (Item # AF2140MBP-K, Case UDI: 30889483083738); UDI-DI: 10889483077573 (Item # AF2140MB-PW, Case UDI: 30889483077577); UDI-DI: 10889483159309 (Item # AF2140MBPW- D23, Case UDI: 30889483159303); UDI-DI: 10889483100424 (Item # AF2140MB-S, Case UDI: 30889483100428); UDI-DI: 10889483097311 (Item # AF2140MC, Case UDI: 20889483097318); UDI-DI: 10889483163344 (Item # AF2140MCP-D4, Case UDI: 30889483163348); UDI-DI: 10889483275788 (Item # AF2140MCPF, Case UDI: 30889483275782); UDI-DI: 10889483158821 (Item # AF2140MCP-K, Case UDI: 30889483158825); UDI-DI: 10889483159347 (Item # AF2140MC-PT, Case UDI: 30889483159341); UDI-DI: 10889483085776 (Item # AF2140OB, Case UDI: 30889483085770); UDI-DI: 10889483090237 (Item # AF2142MB , Case UDI: 30889483090231); UDI-DI: 10889483081167 (Item # AF2142MB-2, Case UDI: 30889483081161); UDI-DI: 10889483077931 (Item # AF2142MB-3, Case UDI: 30889483077935); UDI-DI: 10889483087756 (Item # AF2142MB-D3, Case UDI: 30889483087750); UDI-DI: 10889483088128 (Item # AF2142MB-K, Case UDI: 20889483088125); UDI-DI: 10889483102978 (Item # AF2142MBP, Case UDI: 30889483102972); UDI-DI: 10889483073315 (Item # AF2142MBP-2, Case UDI: 30889483073319); UDI-DI: 10889483097328 (Item # AF2142MBP- 224OT, Case UDI: 20889483097325); UDI-DI: 10889483102961 (Item # AF2142MB-PW, Case UDI: 20889483102968); UDI-DI: 10889483081174 (Item # AF2142MBS-I, Case UDI: 30889483081178); UDI-DI: 10889483081181 (Item # AF2142MC-3 , Case UDI: 30889483081185); UDI-DI: 10889483164136 (Item # AF2142MC-D34, Case UDI: 30889483164130); UDI-DI: 10889483168554 (Item # AF2142MC-M01, Case UDI: 30889483168558); UDI-DI: 10889483087800, (Item # AF2142MCP, Case UDI: 30889483087804); UDI-DI: 10889483167083 (Item # AF2142MCP-D4, Case UDI: 30889483167087); UDI-DI: 10889483089262 (Item # AF2142OB, Case UDI: 30889483089266); UDI-DI: 10889483226285 (Item # AF2142OBNS, Case UDI: 30889483226289); UDI-DI: 10889483078204 (Item # AF2144MB, Case UDI: 20889483078201); UDI-DI: 10889483555675 (Item # AF2142MB-M5E, Case UDI: 30889483555679); UDI-DI: 10889483077948 (Item # AF2242MBP, Case UDI: 20889483077945); UDI-DI: 10889483093542 (Item # AF3100MB, Case UDI: 30889483093546); UDI-DI: 10889483165171 (Item # AF3100MB-2, Case UDI: 30889483165175); UDI-DI: 10889483164556 (Item # AF3100MB-M0, Case UDI: 30889483164550); UDI-DI: 10889483085790 (Item # AF3100MB-M01, Case UDI: 20889483085797); UDI-DI: 10889483100431 (Item # AF3100MB-M0- D1, Case UDI: 30889483100435); UDI-DI: 10889483103432 (Item # AF3100MB-M1, Case UDI: 30889483103436); UDI-DI: 10889483089293 (Item # AF3100MBP, Case UDI: 30889483089297); UDI-DI: 10889483172254 (Item # AF3100MBP-2, Case UDI: 30889483172258); UDI-DI: 10889483159323 (Item # AF3100MBP-D12, Case UDI: 30889483159327); UDI-DI: 10889483083741 (Item # AF3100MBP-M01 Case UDI: 30889483083745 UDI-DI: 10889483158807 (Item # AF3100MBP- M012, Case UDI: 30889483158801); UDI-DI: 10889483165188 (Item # AF3100MBP- M0D1, Case UDI: 30889483165182); UDI-DI: 10889483087770 (Item # AF3100MB-PTS1, Case UDI: 30889483087774); UDI-DI: 10889483097335 (Item # AF3100MB-PW, Case UDI: 30889483097339); UDI-DI: 10889483228708 (Item # AF3100MB-X, Case UDI: 30889483228702); UDI-DI: 10889483081198 (Item # AF3100MC, Case UDI: 20889483081195); UDI-DI: 10889483077108 (Item # AF3100MC-2, Case UDI: 20889483077105); UDI-DI: 10889483089309 (Item # AF3100MCP, Case UDI: 30889483089303); UDI-DI: 10889483107447 (Item # AF3100MCP-2, Case UDI: 30889483107441); UDI-DI: 10889483075517 (Item # AF3100OB, Case UDI: 20889483075514); UDI-DI: 10889483097397 (Item # AF3100OC, Case UDI: 20889483097394); UDI-DI: 10889483172629 (Item # AF3104MB-PW, Case UDI: 30889483172623); UDI-DI: 10889483080023 (Item # AF3106MC-2, Case UDI: 30889483080027); UDI-DI: 10889483095713 (Item # AF3140MB, Case UDI: 30889483095717); UDI-DI: 10889483087220 (Item # AF3140MB-2, Case UDI: 30889483087224); UDI-DI: 10889483077115 (Item # AF3140MB-2B, Case UDI: 30889483077119); UDI-DI: 10889483078099 (Item # AF3140MB-D1, Case UDI: 30889483078093); UDI-DI: 10889483102985 (Item # AF3140MB-D12I, Case UDI: 30889483102989); UDI-DI: 10889483097342 (Item # AF3140MB-D2, Case UDI: 30889483097346); UDI-DI: 10889483087824 (Item # AF3140MB-I, Case UDI: 30889483087828); UDI-DI: 10889483103449 (Item # AF3140MB-K, Case UDI: 30889483103443); UDI-DI: 10889483077214 (Item # AF3140MB-M0, Case UDI: 30889483077218); UDI-DI: 10889483082683 (Item # AF3140MB-M000, Case UDI: 30889483082687); UDI-DI: 10889483102992 (Item # AF3140MB-M1, Case UDI: 30889483102996); UDI-DI: 10889483113011 (Item # AF3140MB-P, Case UDI: 30889483113015); UDI-DI: 10889483096444 (Item # AF3140MBP-2, Case UDI: 30889483096448); UDI-DI: 10889483159910 (Item # AF3140MB-PW, Case UDI: 30889483159914); UDI-DI: 10889483090299 (Item # AF3140MB-S1, Case UDI: 30889483090293); UDI-DI: 10889483079256 (Item # AF3140MC, Case UDI: 30889483079250); UDI-DI: 10889483077597 (Item # AF3140MC-2B, Case UDI: 30889483077591); UDI-DI: 10889483232088 (Item # AF3140MC- M0D12 UDI-DI: 10889483166963 (Item # AF3140MCP, Case UDI: 30889483166967); UDI-DI: 10889483275771 (Item # AF3140MCPF, Case UDI: 30889483275775); UDI-DI: 1088948315881 (Item # AF3140MCP-K, Case UDI: 30889483158818); UDI-DI: 10889483097410 (Item # AF3140OB, Case UDI: 30889483097414); UDI-DI: 10889483078105 (Item # AF3144MB, Case UDI: 30889483078109); UDI-DI: 10889483272626 (Item # AF3144MCP- M1M00, Case UDI: 30889483272620); UDI-DI: 10889483090305 (Item # AF4100MB, Case UDI: 30889483090309); UDI-DI: 10889483160121 (Item # AF4100MBP, Case UDI: 30889483160125); UDI-DI: 10889483182246 (Item # AF4100MCP, Case UDI: 30889483182240); UDI-DI: 10889483098417 (Item # AF4100OB, Case UDI: 30889483098411); UDI-DI: 10889483077627 (Item # AF4140MB, Case UDI: 30889483077621); UDI-DI: 10889483090510 (Item # AF4140MB-D23, Case UDI: 30889483090514); UDI-DI: 10889483093559 (Item # AF4140MB-I, Case UDI: 30889483093553); UDI-DI: 10889483099209 (Item # AF4140MBP, Case UDI: 30889483099203); UDI-DI: 10889483079287 (Item # AF4140MB-PI, Case UDI: 30889483079281); UDI-DI: 10889483087237 (Item # AF4140MC, Case UDI: 30889483087231); UDI-DI: 10889483163337 (Item # AF4140MCP-D3, Case UDI: 30889483163331); UDI-DI: 10889483090527 (Item # AF4140OBP, Case UDI: 30889483090521); UDI-DI: 10889483089323 (Item # AF5100MB, Case UDI: 30889483089327); UDI-DI: 10889483089330 (Item # AF5100MB-D5, Case UDI: 30889483089334); UDI-DI: 10889483159224 (Item # AF5100MB-PW, Case UDI: 30889483159228); UDI-DI: 10889483099346 (Item # AF5100MC, Case UDI: 30889483099340); UDI-DI: 10889483171929 (Item # AF5102MB-N, Case UDI: 30889483171923); UDI-DI: 10889483165164 (Item # AF5102MBP, Case UDI: 30889483165168); UDI-DI: 10889483103012 (Item # AF5140MB, Case UDI: 30889483103016); UDI-DI: 10889483079881 (Item # AF5140MB-2, Case UDI: 30889483079885); UDI-DI: 10889483089606 (Item # AF5140MB-D6, Case UDI: 30889483089600); UDI-DI: 10889483083758 (Item # AF5140MB-F, Case UDI: 30889483083752); UDI-DI: 10889483087251 (Item # AF5140MB-I, Case UDI: 30889483087255); UDI-DI: 10889483082720 (Item # AF5140MB-K, Case UDI: 30889483082724); UDI-DI: 10889483162408 (Item # AF5140MB-M5, Case UDI: 30889483162402); UDI-DI: 10889483090275 (Item # AF5140MBN, Case UDI: 30889483090279); UDI-DI: 10889483103029 (Item # AF5140MB-OT, Case UDI: 30889483103023); UDI-DI 10889483074725 (Item # AF5140MBP, Case UDI: 30889483074729 UDI-DI: 10889483098431 (Item # AF5140MBP-D5, Case UDI: 30889483098435); UDI-DI: 10889483104682 (Item # AF5140MBP-D6, Case UDI: 30889483104686); UDI-DI: 10889483275757 (Item # AF5140MBPF-G10, Case UDI: 30889483275751); UDI-DI: 10889483171967 (Item # AF5140MBP-G10, Case UDI: 30889483171961); UDI-DI: 10889483072233 (Item # AF5140MBP-I , Case UDI: 30889483072237); UDI-DI: 10889483163085 (Item # AF5140MBP-M5, Case UDI: 30889483163089); UDI-DI: 10889483089347 (Item # AF5140MB-PT, Case UDI: 30889483089341); UDI-DI: 10889483080061 (Item # AF5140MB-PW, Case UDI: 30889483080065); UDI-DI: 10889483099216 (Item # AF5140MBPW-D5, Case UDI: 30889483099210); UDI-DI: 10889483162514 (Item # AF5140MBPW- M5, Case UDI: 30889483162518); UDI-DI: 10889483079133 (Item # AF5140MBPWTD5, Case UDI: 30889483079137); UDI-DI: 10889483083772 (Item # AF5140MBS, Case UDI: 30889483083776); UDI-DI: 10889483077139 (Item # AF5140MBS-I, Case UDI: 30889483077133); UDI-DI: 10889483162231 (Item # AF5140MBS-M5, Case UDI: 30889483162235); UDI-DI: 10889483087268 (Item # AF5140MBS-P, Case UDI: 30889483087262); UDI-DI: 10889483083789 (Item # AF5140MBS-R, Case UDI: 30889483083783); UDI-DI: 10889483092682 (Item # AF5140MB-ST, Case UDI: 30889483092686); UDI-DI: 10889483083765 (Item # AF5140MB-T, Case UDI: 30889483083769); UDI-DI: 10889483227619 (Item # AF5140MB-X, Case UDI: 30889483227613); UDI-DI: 10889483090282 (Item # AF5140MC, Case UDI: 30889483090286); UDI-DI: 10889483228241 (Item # AF5140MC-D6, Case UDI: 30889483228245); UDI-DI: 10889483104200 (Item # AF5140MC-P, Case UDI: 30889483104204); UDI-DI: 10889483158838 (Item # AF5140MCP-K, Case UDI: 30889483158832); UDI-DI: 10889483089613 (Item # AF5142MB, Case UDI: 30889483089617); UDI-DI: 10889483227305 (Item # AF5142MB-D235, Case UDI: 30889483227309); UDI-DI: 10889483091838 (Item # AF5142MBP, Case UDI: 30889483091832); UDI-DI: 10889483163177 (Item # AF5142MBP-M5, Case UDI: 30889483163171); UDI-DI: 10889483080078 (Item # AF5142OB, Case UDI: 30889483080072); UDI-DI: 10889483085127 (Item # AFD5140MB-T, Case UDI: 30889483085121); UDI-DI: 10889483162781 (Item # AFN5140MB, Case UDI: 30889483162785); UDI-DI: 10889483099247 (Item # AFW1140MB, Case UDI: 30889483099241 UDI-DI: 10889483092705 (Item# AFW2142MB-2, Case UDI: 30889483092709); UDI-DI: 10889483078709 (Item # AFW2142OB, Case UDI: 30889483078703). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.
Center Classification Date20231121
Recall Initiation Date20231011
Recalling FirmSunMed Holdings, LLC
Initial Notification E-Mail
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