Recall Z-2088-2023 ยท KDD Kit, Surgical Instrument, Disposable
DeRoyal Industries Inc
Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HIP PACK, REF 89-9134 f) EMERGENCY C-SECTION PACK, REF 89-9478
| Date | Jul 3, 2023 (initiated May 30, 2023) |
| Status | Open, Classified |
| Reason | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. |
| Root cause | Process control |
| Action | DeRoyal disseminated an URGENT! DEROYAL RECALL NOTICE to its consignees on 05/30/2023 by email. The notice explained the issue, the risk, and requested the return of the affected products. Distributors were also directed to identify and notify their customers. |
| Quantity | 328 packs |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.