Z-2087-2023 Class II Ongoing
FDA device recall Z-2087-2023 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: 40 units.
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
- 40 units
Product Description
Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
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 '89-5014, GTIN 50749756217908 (cs), 00749756217903 (unit), , Lot Numbers: 58770294