Recall Z-0914-2025 ยท OHD Gynecological Laparoscopic Kit
Cardinal Health 200, LLC
Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11FSC10 2 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH5 3 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH6 4 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH7 5 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH8 6 ) KIT, FETAL SURGERY , Catalog Number PB11FSCH9 7 ) KIT, FETAL SURGERY , Catalog Number PB11FSCHR
| Date | Jan 15, 2025 (initiated Nov 8, 2024) |
| Status | Open, Classified |
| Reason | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. |
| Root cause | Nonconforming Material/Component |
| Action | An URGENT: PRODUCT RECALL notification letter dated 11/8/24 was sent to customers. If you locate affected product within your facility, please complete the following: 1. REVIEW your inventory immediately stop using the affected product code and lots attached. 2. COMMUNICATE with all personnel who utilize the Presource Kits containing CODMAN Patties & Strips component produced by Integra LifeSciences. 3. NOTIFY any customers to whom you may have distributed/forwarded affected product or to whom you plan to send the product about this medical device product correction and share a copy of this n |
| Quantity | 512,786 total units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.