Device product
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
Z-1981-2019
Product summary
- Event
- Event 83154
- Status
- Terminated
- Classification
- Class II
- Quantity
- 108 units
- Official record key
device-enforcement:Z-1981-2019
Official wording
Reason: 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.
Code information: Lot 49888830
Distribution pattern: US Distribution to: OK
Derived failure modes
-
Manufacturing or process control
manufacturing defect