Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
This recall is currently active, issued July 3, 2023. It was issued by Deroyal Industries Inc.
- Company
- Deroyal Industries Inc
- Recall Initiated
- May 30, 2023
- Posted
- July 3, 2023
- Recall Number
- Z-2090-2023
- Quantity
- 306 packs
- Firm Location
- Powell, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Distribution
US Nationwide distribution.
Lot / Code Info
a) REF 89-7102, GTIN 50749756734085 (cs), 00749756734080 (unit), Lot Numbers: 58806701; b) REF 89-7322, GTIN 50749756736171 (cs), 00749756736176 (unit), Lot Numbers: 58821231; c) REF 89-9183, GTIN '0749756904846 (cs), 00749756904841 (unit), Lot Numbers: 58741944
Root Cause
Process control
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.