Recall Z-2635-2024 ยท OGJ Nerve Block Tray
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits, labeled as: 1) NERVE STIMULATOR, Pack Number CDS981579O ; 2) DR DIULUS INJECTION PACK, Pack Number DYNDA2391; 3) BLOCK KIT , Pack Number DYNDA2508; 4) NERVE BLOCK PAIN PACK, Pack Number DYNDL1389; 5) BLOCK TRAY-LF , Pack Number DYNJ0117039; 6) NERVE BLOCK ACCESSORY PACK, Pack Number DYNJ0134147D ; 7) UNIVERSAL PROC TRAY-LF, Pack Number DYNJ02120B ; 8) ANGIO PROCE
| Date | Aug 27, 2024 (initiated Apr 8, 2024) |
| Status | Open, Classified |
| Reason | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. |
| Root cause | Nonconforming Material/Component |
| Action | Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other pr |
| Quantity | 1,679,067 units in total |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.