Recall Z-1389-2024 ยท MDM Instrument, Manual, Surgical, General Use
Applied Medical Resources Corp
Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - HPATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT, GK1033, AME STANDARD KIT 21-023, GK1044, KE39830 COLE, GK1047, AME STANDARD KIT 22-003, GK1063, AME STANDARD KIT 22-022, GK1068,
| Date | Mar 27, 2024 (initiated Jan 30, 2024) |
| Status | Open, Classified |
| Reason | Their is the potential that Universal Clip applier may not load clip after the trigger is actuated. |
| Root cause | Under Investigation by firm |
| Action | On February 16, 2024, Applied Medical issued a "Urgent: Medical Device Recall" notification to affected consignees via UPS. In addition, to informing consignees about the recall, Applied Medical asked consignees to take the following actions: " Check your inventory for recalled product. " Quarantine any product from the impacted lots above (Page 1) or kits listed below (Page 7-10). " Complete the attached Distributor Recall Notification Confirmation Form (Page 4) to acknowledge the recall and indicate if your facility is returning or has already used the lots listed above. o If no product i |
| Quantity | 17,990 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Algeria, Argentina, A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.