Z-1981-2019 Class II Terminated
FDA device recall Z-1981-2019 was initiated by DeRoyal Industries Inc on June 18, 2019 and is designated Class II. Reason for recall: Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the ster… The recall status is terminated (terminated September 16, 2020). Affected quantity: 108 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 24, 2019
- Initiation Date
- June 18, 2019
- Termination Date
- September 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 108 units
Product Description
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
Reason for Recall
Custom surgical packs are being recalled because it contains Cardinal Health Blunt Cannulas which were recalled due to a manufacturing defect in the cartridge component which could compromise the sterility barrier of the product.
Distribution Pattern
US Distribution to: OK
Code Information
Lot 49888830