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Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated...

FDA Recall #Z-1280-2020 — Class II — December 18, 2019

Recall #Z-1280-2020 Date: December 18, 2019 Classification: Class II Status: Terminated

Product Description

Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.

Reason for Recall

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

Recalling Firm

Covidien LLC — North Haven, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

139,938 units total

Distribution

US Nationwide distribution.

Code Information

Lot - D7H1048X Expiration Date - 2022-08-31

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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