FDAClass IIAugust 1, 2018

PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture recall

PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)

Why was PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture recalled?

Products do not meet a tensile strength specification

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 Number:MCZ162

Product
PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
Recalling firm
Ethicon, Inc.
Quantity
756
Distribution
Japan
Recall date
August 1, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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