Z-2090-2023 Class II Ongoing
FDA device recall Z-2090-2023 was initiated by DeRoyal Industries Inc on May 30, 2023 and is designated Class II. Reason for recall: The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. The recall status is ongoing. Affected quantity: 306 packs.
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2023
- Initiation Date
- May 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 306 packs
Product Description
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
Reason for Recall
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Distribution Pattern
US Nationwide distribution.
Code Information
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