FDAClass IIMay 27, 2015

DeRoyal(R) Medium Specimen Retrieval Bag recall

DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use…

Why was DeRoyal(R) Medium Specimen Retrieval Bag recalled?

The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.

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?

1211QDA403, 1301QDA402, 1301QDA410, 1303QDA401, 211QDA403, 32046564, 32119911, 32338381, 32562251, 32783812, 32886441, 32891051, 32899882, 32942609, 33114274, 34939294, 35229930, 35579999, 35738515

Product
DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use…
Recalling firm
DeRoyal Industries Inc
Quantity
5359 units
Distribution
US Nationwide Distribution
Recall date
May 27, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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