Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
- Company
- Deroyal Industries Inc
- Recall Initiated
- May 30, 2023
- Posted
- July 3, 2023
- Recall Number
- Z-2089-2023
- Quantity
- 3 packs
- Firm Location
- Powell, TN
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 89-6219, GTIN 50749756664382 (cs), 00749756664387 (unit), Lot Numbers: 58807114
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.
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