FDAClass IIJuly 24, 2019

Deroyal the Resource Group recall: Sterility Concern

DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack

Why was Deroyal the Resource Group 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 49888830

Product
DeRoyal THE RESOURCE GROUP, CRANI PACK, REF 89-9211.07 custom surgical pack
Recalling firm
DeRoyal Industries Inc
Quantity
108 units
Distribution
US Distribution to: OK
Recall date
July 24, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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