DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
Reported: July 24, 2019 Initiated: June 18, 2019 #Z-1981-2019
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.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 108 units
- Distribution
- US Distribution to: OK
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack. Recalled by DeRoyal Industries Inc. Units affected: 108 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2019. Severity: Moderate. Recall number: Z-1981-2019.
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