Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7
FDA device recall Z-2090-2023 · 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
- OEQ
- Quantity affected
- 306 packs
- Distribution
- US Nationwide distribution.
- Date initiated
- 2023-05-30
- Date posted
- 2023-07-03
- Location
- Powell, TN
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