Recall Z-2327-2024 ยท OEQ Angiography/Angioplasty Kit
Cardinal Health 200, LLC
Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608; 5) ANGIOGRAPHY PACK, Catalog Number SAN13BS609; 6) STERILE ANGIOGRAPHY PACK, Catalog Number SAN13BS60K; 7) ANGIOGRAPHY PACK, Catalog Number SAN13BS60L; 8) ANGIOG
| Date | Jul 10, 2024 (initiated May 29, 2024) |
| Status | Open, Classified |
| Reason | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied finished kits. Merit Medical supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of |
| Root cause | Device Design |
| Action | Cardinal Health issued an URGENT: PRODUCT RECALL notice to its consignees on 05/28/2024 via letter. The notice explained the issue, potential risks involved, and requested the following: "If you locate affected product within your facility, please complete the following: 1. QUARANTINE affected kits & ALERT your clinicians of this action 2. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard all syringes within the affected Merit Medical kit in the Presource product. 3. RETURN a copy of the enclosed Ack |
| Quantity | 136753 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.