FDAClass IIDecember 26, 2012

Medline Angio Drape Pack Radiology-LF recall: Sterility Concern

Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the…

Why was Medline Angio Drape Pack Radiology-LF recalled?

The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in its own packaging. The product was not labeled or identified as sterile, but was assumed to be sterile by the customer.

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?

Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015

Product
Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the…
Recalling firm
Medline Industries Inc
Quantity
105 packs
Distribution
Nationwide distribution: New York only.
Recall date
December 26, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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