Recall Z-3017-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097D
| Date | Sep 6, 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 | Under Investigation by firm |
| 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 |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974279 | 3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C) 3M Healthcare, Jan 30, 1998 |