FDAFDA · Food and drugs·Recall number Z-1981-2019
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
Published July 24, 2019 · Recall initiated: June 18, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- DeRoyal Industries Inc
- Distributor
- US Distribution to: OK
- Lot
- Lot 49888830
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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