Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c
FDA device recall Z-2086-2023 · posted 2023-07-03 · Open, Classified
Recall details
- Recalling firm
- DeRoyal Industries Inc
- Reason for recall
- The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 4225 packs
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-05-30
- Date posted
- 2023-07-03
- Location
- Powell, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENERAL SURGERY TRAY (K842648) | Deroyal Industries, Inc. | 1984-09-20 |