FDAClass IIFebruary 26, 2020

Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10 recall: Sterility Concern

Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation…

Why was Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10 recalled?

There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots.

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 -D7H1214X Expiration Date - 2022-08-31

Product
Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - Product Usage: Indicated for use in soft tissue approximation or ligation…
Recalling firm
Covidien LLC
Quantity
139,938 units total
Distribution
US Nationwide distribution.
Recall date
February 26, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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