FDAClass IINovember 14, 2018

Endoform Dermal Template 2x2 recall

Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular…

Why was Endoform Dermal Template 2x2 recalled?

Potential for pouch seal failure

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 numbers: EDT-7I01 EDT-7K01 EDT-7L05

Product
Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular…
Recalling firm
AROA BIOSURGERY
Quantity
8,853 total boxes
Distribution
US Nationwide Distribution
Recall date
November 14, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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