MEDLINE INDUSTRIES, LP – Northfield Recall 91386
Description: Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k. PK, ROBOTICS-ACCESSORY l. OBS PACK m. LAPAROSCOPY/D&C PACK n. PERI GYN RECTAL PACK o. TVT p. DAVINCI DT-LF q. ROBOTICS SI
MEDLINE INDUSTRIES, LP – Northfield Recall 91386 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1094-2023 |
| Event ID | 91386 |
| Event Description | Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k. PK, ROBOTICS-ACCESSORY l. OBS PACK m. LAPAROSCOPY/D&C PACK n. PERI GYN RECTAL PACK o. TVT p. DAVINCI DT-LF q. ROBOTICS SI |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates. |
| Quantity | 1,212 cases (2,101 units) |
| Recall Reason | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
| Device Classification | 20230215 |
| Device Code Info | a. CELEBRATION ROBOTIC CDS, Item Number: CDS983612C, Case UDI/GTIN: 40884389768687, Unit UDI/GTIN: 10884389768686, Lot Number: 22KBE707,22JBX839,22JBX843; b. DAVINCI CDS UCC-LF, Item Number: CDS984663G, Case UDI/GTIN: 40193489323772, Unit UDI/GTIN: 10193489323771, Lot Number: 22JBX614; c. ROBOTICS PACK-LF, Item Number: DYNJ0038258B, Case UDI/GTIN: 40889942902089, Unit UDI/GTIN: 10889942902088, Lot Number: 22IBO524,22HBV626,22HBV627; d. ROBOTICS PACK-LF, Item Number: DYNJ0046667A, Case UDI/GTIN: 40889942160397, Unit UDI/GTIN: 10889942160396, Lot Number: 22JMA806,22IMC899; e. ROBOTIC PACK, Item Number: DYNJ04135B, Case UDI/GTIN: 40888277893536, Unit UDI/GTIN: 10888277893535, Lot Number: 22JBX625,22IBE470; f. PELVISCOPY PACK-LF, Item Number: DYNJ0843760G, Case UDI/GTIN: 40193489899161, Unit UDI/GTIN: 10193489899160, Lot Number: 22IDC034; g. CUSTOM LITHOTOMY ROBOT PACK, Item Number: DYNJ35094C, Case UDI/GTIN: 40889942764991, Unit UDI/GTIN: 10889942764990, Lot Number: 22IBR203; h. PERI GYN PACK, Item Number: DYNJ39021B, Case UDI/GTIN: 40195327191048, Unit UDI/GTIN: 10195327191047, Lot Number: 22JBI763,22IBJ622; i. ROBOTICS PACK, Item Number: DYNJ42016B, Case UDI/GTIN: 40888277938312, Unit UDI/GTIN: 10888277938311, Lot Number: 22JBQ809,22IBG293; j. LAP HYSTO PACK, Item Number: DYNJ43888, Case UDI/GTIN: 40888277073273, Unit UDI/GTIN: 10888277073272, Lot Number: 22JBC458; k. PK, ROBOTICS-ACCESSORY, Item Number: DYNJ52985F, Case UDI/GTIN: 40193489215824, Unit UDI/GTIN: 10193489215823, Lot Number: 22IBK173,22IBK797,22HBG975; l. OBS PACK, Item Number: DYNJ65258B, Case UDI/GTIN: 40193489829496, Unit UDI/GTIN: 10193489829495, Lot Number: 22IBD122; m. LAPAROSCOPY/D&C PACK, Item Number: DYNJ67569A, Case UDI/GTIN: 40195327191529, Unit UDI/GTIN: 10195327191528, Lot Number: 22JBQ481; n. PERI GYN RECTAL PACK, Item Number: DYNJ82556, Case UDI/GTIN: 40195327198269, Unit UDI/GTIN: 10195327198268, Lot Number: 22IBO110; o. TVT, Item Number: DYNJ900506B, Case UDI/GTIN: 40889942576518, Unit UDI/GTIN: 10889942576517, Lot Number: 22IBV025; p. DAVINCI DT-LF, Item Number: DYNJ900569G, Case UDI/GTIN: 40193489861434, Unit UDI/GTIN: 10193489861433, Lot Number: 22JBB568; q. ROBOTICS SI, Item Number: DYNJ902659D, Case UDI/GTIN: 40889942692416, Unit UDI/GTIN: 10889942692415, Lot Number: 22IBG173,22IBG174 |
| Center Classification Date | 20230206 |
| Recall Initiation Date | 20221117 |
| Recalling Firm | MEDLINE INDUSTRIES, LP - Northfield |
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