Recall Z-2088-2023
DeRoyal Industries Inc · initiated May 30, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: a) REF 89-10640, GTIN 50749756367740 (cs), 00749756367745 (unit), Lot Numbers: 58737945; b) REF 89-10901, GTIN 50749756380244 (cs), 00749756380249 (unit), Lot Numbers: 58820749; c) REF 89-1924, GTIN 50749756216864 (cs), 00749756216869 (unit), Lot Numbers: 58746227; d) REF 89-7133, GTIN 50749756736744 (cs), 00749756736749 (unit), Lot Numbers: 58789323; e) REF 89-9134, GTIN 50749756911332 (cs), 00749756911337 (unit), Lot Numbers: 58701336; f) REF 89-9478, GTIN 50749756926909 (cs), 00749756926904 (unit), Lot Numbers: 58738454
Reason for recall
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
FDA-determined 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.
Details
- Recall number
- Z-2088-2023
- Initiated
- May 30, 2023
- Posted by FDA
- July 3, 2023
- Product code
- KDD – Kit, Surgical Instrument, Disposable
- Quantity
- 328 packs
- Distribution
- US Nationwide distribution.
- Recalling firm
- DeRoyal Industries Inc, Powell, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2086-2023 Class II | Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b)…The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | 05/30/2023Open, Classified |
| Z-2087-2023 Class II | Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | 05/30/2023Open, Classified |
| Z-2089-2023 Class II | Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | 05/30/2023Open, Classified |
| Z-2090-2023 Class II | Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102…The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | 05/30/2023Open, Classified |