MEDLINE INDUSTRIES, LP – Northfield Recall 92466
Description: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24526P; f) TOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L; g) TOTAL KNEE PACK 319735, Model Number DYNJ44635I; h) HIP ARTHROPLASTY PACK, Model Number DYNJ50072F; i) LEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L; j) TOTAL JOINT, Model Number DYNJ57827D; k) ANTERIOR HIP PACK, Model Number DYNJ59126B; l) TOTAL HIP PACK, Model Number DYNJ60918A; m) MAIN TOTAL JOINT, Model Number DYNJ61376C; n) TOTAL HIP PACK, Model Number DYNJ63383; o) ANTERIOR PACK, Model Number DYNJ64814A; p) TOTAL JOINT PACK, Model Number DYNJ64951; q) TOTAL KNEE PACK-EOSC, Model Number DYNJ65093B; r) TOTAL KNEE PACK-CSC, Model Number DYNJ65108F; s) MERCY ANTERIOR HIP, Model Number DYNJ66913A; t) TOTAL PACK, Model Number DYNJ68468C; u) TOTAL KNEE-LF, Model Number DYNJ69153F; v) TOTAL JOINT PACK, Model Number DYNJ80372B; w) ANTERIOR HIP PACK, Model Number DYNJ82038; x) HIP PACK, Model Number DYNJ82345A; y) TOTAL HIP PACK, Model Number DYNJ82627A; z) TOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553; aa) TOTAL JOINT PACK, Model Number DYNJ83567A; bb) TOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885; cc) HIP PACK, Model Number DYNJ84051; dd) TOTAL KNEE PACK, Model Number DYNJ84054; ee) OISC HAND KORCEK, Model Number DYNJ902351F; ff) TOTAL HIP, Model Number DYNJ903149D; gg) OISC TOTAL HIP BOTTROS, Model Number DYNJ904154O; hh) TOTAL HIP, Model Number DYNJ904331I; ii) TOTAL KNEE, Model Number DYNJ904332J; jj) CRANIOTOMY, Model Number DYNJ905330B; kk) TRAUMA-RAMA, Model Number DYNJ905886G; ll) ANTERIOR HIP, Model Number DYNJ907831D; mm) TOTAL HIP-LF, Model Number DYNJ908127B; nn) TOTAL KNEE-LF, Model Number DYNJ908128B; oo) TOTAL HIP CDS, Model Number DYNJ908331A; pp) TOTAL KNEE THEDA, Model Number DYNJ908683A; qq) TOTAL HIP-LF, Model Number DYNJ909000; rr) TOTAL KNEE-LF, Model Number DYNJ909002; ss) TOTAL HIP, Model Number DYNJ909198A; tt) HIP MOFFIT PPS-LF, Model Number DYNJ9428703Q; uu) LOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R; vv) UPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O
MEDLINE INDUSTRIES, LP – Northfield Recall 92466 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2205-2023 |
| Event ID | 92466 |
| Event Description | Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24526P; f) TOTAL KNEE ARTHROPLASTY PACK, Model Number DYNJ26425L; g) TOTAL KNEE PACK 319735, Model Number DYNJ44635I; h) HIP ARTHROPLASTY PACK, Model Number DYNJ50072F; i) LEXINGTON TOTAL JOINT PACK, Model Number DYNJ55655L; j) TOTAL JOINT, Model Number DYNJ57827D; k) ANTERIOR HIP PACK, Model Number DYNJ59126B; l) TOTAL HIP PACK, Model Number DYNJ60918A; m) MAIN TOTAL JOINT, Model Number DYNJ61376C; n) TOTAL HIP PACK, Model Number DYNJ63383; o) ANTERIOR PACK, Model Number DYNJ64814A; p) TOTAL JOINT PACK, Model Number DYNJ64951; q) TOTAL KNEE PACK-EOSC, Model Number DYNJ65093B; r) TOTAL KNEE PACK-CSC, Model Number DYNJ65108F; s) MERCY ANTERIOR HIP, Model Number DYNJ66913A; t) TOTAL PACK, Model Number DYNJ68468C; u) TOTAL KNEE-LF, Model Number DYNJ69153F; v) TOTAL JOINT PACK, Model Number DYNJ80372B; w) ANTERIOR HIP PACK, Model Number DYNJ82038; x) HIP PACK, Model Number DYNJ82345A; y) TOTAL HIP PACK, Model Number DYNJ82627A; z) TOTAL KNEE PACK LEXINGTON CLIN, Model Number DYNJ83553; aa) TOTAL JOINT PACK, Model Number DYNJ83567A; bb) TOTAL KNEE ACCESSORY PACK, Model Number DYNJ83885; cc) HIP PACK, Model Number DYNJ84051; dd) TOTAL KNEE PACK, Model Number DYNJ84054; ee) OISC HAND KORCEK, Model Number DYNJ902351F; ff) TOTAL HIP, Model Number DYNJ903149D; gg) OISC TOTAL HIP BOTTROS, Model Number DYNJ904154O; hh) TOTAL HIP, Model Number DYNJ904331I; ii) TOTAL KNEE, Model Number DYNJ904332J; jj) CRANIOTOMY, Model Number DYNJ905330B; kk) TRAUMA-RAMA, Model Number DYNJ905886G; ll) ANTERIOR HIP, Model Number DYNJ907831D; mm) TOTAL HIP-LF, Model Number DYNJ908127B; nn) TOTAL KNEE-LF, Model Number DYNJ908128B; oo) TOTAL HIP CDS, Model Number DYNJ908331A; pp) TOTAL KNEE THEDA, Model Number DYNJ908683A; qq) TOTAL HIP-LF, Model Number DYNJ909000; rr) TOTAL KNEE-LF, Model Number DYNJ909002; ss) TOTAL HIP, Model Number DYNJ909198A; tt) HIP MOFFIT PPS-LF, Model Number DYNJ9428703Q; uu) LOWER EXTREMITY PPS-LF, Model Number DYNJ9428745R; vv) UPPER EXTREMITY SHOULDER PPS, Model Number DYNJ9428787O |
| Product Type | Devices |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia. |
| Quantity | 4500 units |
| Recall Reason | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| Device Classification | 20230726 |
| Device Code Info | a) Model Number CDS985555S, UDI/DI (EA) 10195327343798, UDI/DI (CS) 40195327343799; b) Model Number CDS985566Q, UDI/DI (EA) 10195327074418, UDI/DI (CS) 40195327074419; c) Model Number DYNJ0949139I, UDI/DI (EA) 10195327195366, UDI/DI (CS) 40195327195367; d) Model Number DYNJ24525K, UDI/DI (EA) 10195327135751, UDI/DI (CS) 40195327135752; e) Model Number DYNJ24526P, UDI/DI (EA) 10195327135744, UDI/DI (CS) 40195327135745; f) Model Number DYNJ26425L, UDI/DI (EA) 10195327156985, UDI/DI (CS) 40195327156986; g) Model Number DYNJ44635I, UDI/DI (EA) 10193489958553, UDI/DI (CS) 40193489958554; h) Model Number DYNJ50072F, UDI/DI (EA) 10193489340921, UDI/DI (CS) 40193489340922; i) Model Number DYNJ55655L, UDI/DI (EA) 10195327102029, UDI/DI (CS) 40195327102020; j) Model Number DYNJ57827D, UDI/DI (EA) 10193489910636, UDI/DI (CS) 40193489920637; k) Model Number DYNJ59126B, UDI/DI (EA) 10193489395983, UDI/DI (CS) 40193489395984; l) Model Number DYNJ60918A, UDI/DI (EA) 10193489257946, UDI/DI (CS) 40193489257947; m) Model Number DYNJ61376C, UDI/DI (EA) 10195327295066, UDI/DI (CS) 40195327295067; n) Model Number DYNJ63383, UDI/DI (EA) 10193489735109, UDI/DI (CS) 40193489735100; o) Model Number DYNJ64814A, UDI/DI (EA) 10195327112806, UDI/DI (CS) 40195327112807; p) Model Number DYNJ64951, UDI/DI (EA) 10193489236224, UDI/DI (CS) 40193489236225; q) Model Number DYNJ65093B, UDI/DI (EA) 10195327177508, UDI/DI (CS) 40195327177509; r) Model Number DYNJ65108F, UDI/DI (EA) 10195327256241, UDI/DI (CS) 40195327256242; s) Model Number DYNJ66913A, UDI/DI (EA) 10193489996234, UDI/DI (CS) 40193489996235; t) Model Number DYNJ68468C, UDI/DI (EA) 10195327097370, UDI/DI (CS) 40195327097371; u) Model Number DYNJ69153F, UDI/DI (EA) 10195327332679, UDI/DI (CS) 40195327332670; v) Model Number DYNJ80372B, UDI/DI (EA) 10195327244156, UDI/DI (CS) 40195327244157; w) Model Number DYNJ82038, UDI/DI (EA) 10195327163372, UDI/DI (CS) 40195327163373; x) Model Number DYNJ82345A, UDI/DI (EA) 10195327216556, UDI/DI (CS) 40195327316557; y) Model Number DYNJ82627A, UDI/DI (EA) 10195327333331, UDI/DI (CS) 40195327333332; z) Model Number DYNJ83553, UDI/DI (EA) 10195327279356, UDI/DI (CS) 40195327279357; aa) Model Number DYNJ83567A, UDI/DI (EA) 10195327343033, UDI/DI (CS) 40195327343034; bb) Model Number DYNJ83885, UDI/DI (EA) 10195327312237, UDI/DI (CS) 40195327312238; cc) Model Number DYNJ84051, UDI/DI (EA) 10195327330316, UDI/DI (CS) 40195327330317; dd) Model Number DYNJ84054, UDI/DI (EA) 10195327330347, UDI/DI (CS) 40195327330348; ee) Model Number DYNJ902351F, UDI/DI (EA) 10195327318420, UDI/DI (CS) 40195327318421; ff) Model Number DYNJ903149D, UDI/DI (EA) 10195327271139, UDI/DI (CS) 40195327261130; gg) Model Number DYNJ904154O, UDI/DI (EA) 10195327318604, UDI/DI (CS) 40195327318605; hh) Model Number DYNJ904331I, UDI/DI (EA) 10195327025700, UDI/DI (CS) 40195327025701; ii) Model Number DYNJ904332J, UDI/DI (EA) 10195327025694, UDI/DI (CS) 40195327025695; jj) Model Number DYNJ905330B, UDI/DI (EA) 10193489781502, UDI/DI (CS) 40193489781503; kk) Model Number DYNJ905886G, UDI/DI (EA) 10195327329167, UDI/DI (CS) 40195327329168; ll) Model Number DYNJ907831D, UDI/DI (EA) 10195327239701, UDI/DI (CS) 40195327239702; mm) Model Number DYNJ908127B, UDI/DI (EA) 10195327349929, UDI/DI (CS) 40195327349920; nn) Model Number DYNJ908128B, UDI/DI (EA) 10195327349912, UDI/DI (CS) 40195327349913; oo) Model Number DYNJ908331A, UDI/DI (EA) 10195327190156, UDI/DI (CS) 40195327190157; pp) Model Number DYNJ908683A, UDI/DI (EA) 10195327251772, UDI/DI (CS) 40195327251773; qq) Model Number DYNJ909000, UDI/DI (EA) 10195327238100, UDI/DI (CS) 40195327238101; rr) Model Number DYNJ909002, UDI/DI (EA) 10195327238148, UDI/DI (CS) 40195327238149; ss) Model Number DYNJ909198A, UDI/DI (EA) 10195327414788, UDI/DI (CS) 40195327414789; tt) Model Number DYNJ9428703Q, UDI/DI (EA) 10195327329174, UDI/DI (CS) 40195327329175; uu) Model Number DYNJ9428745R, UDI/DI (EA) 10195327258368, UDI/DI (CS) 40195327258369; vv) Model Number DYNJ9428787O, UDI/DI (EA) 10195327328795, UDI/DI (CS) 40195327328795; All lots within expiry, distributed from Medline between December 2017 - May 2023: |
| Center Classification Date | 20230720 |
| Recall Initiation Date | 20230518 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Initial Notification | Letter |
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