Recall Z-2090-2023
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) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
Codes / lots: 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
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-2090-2023
- Initiated
- May 30, 2023
- Posted by FDA
- July 3, 2023
- Product code
- OEQ – Angiography/Angioplasty Kit
- Quantity
- 306 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-2088-2023 Class II | Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF…The 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 |