Polysorb Braided Absorbable Suture Recalled for Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact the humidity or sterility barrier.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the potential loss of sterility in a medical device used for surgical procedures.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322, manufactured by Covidien LLC. The recall affects 139,938 units distributed nationwide in the United States.
The recall is being conducted because there is a potential for packaging integrity issues that may impact the humidity or sterility barrier of specific production lots. The affected lot is D7G0387X with an expiration date of July 31, 2022. The product is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Healthcare providers and facilities should stop using the affected lots and contact the recalling firm for further instructions. Consumers should not use this product if they have it in their possession.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Surgical Suture
- Affected units
- 139,938
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot - D7G0387X Expiration Date - 2022-07-31
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 27 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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