FDAClass IIApril 24, 2019

PDS II Suture 18"(45cm) 2-0 VIO recall

PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric…

Why was PDS II Suture 18"(45cm) 2-0 VIO recalled?

VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.

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 Code: MGM110

Product
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric…
Recalling firm
Ethicon, Inc.
Quantity
550,681 eaches (WW) Total
Distribution
Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE
Recall date
April 24, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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