Agency classClass IIOur severity:High FDA (Devices)·Z-1282-2020·Announced 2020-02-26

FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues

The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of sterility in a medical device used in surgery, which presents a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915, manufactured by Covidien LLC. The recall involves 139,938 units distributed nationwide in the United States. The specific lots affected are A9H0927Y, A9H1187Y, A9J0383Y, and A9J0428Y, with expiration dates ranging from July 31, 2024, to August 31, 2024.

The recall was initiated due to potential packaging integrity issues that could impact the humidity or sterility barrier of the product. This defect poses a risk to the sterility of the sutures, which are indicated for use in soft tissue approximation, ligation, and ophthalmic surgery. The product is not indicated for use in cardiovascular or neural tissue.

Healthcare providers and facilities that have received these specific lots should stop using the product and contact the manufacturer for further instructions. Consumers should not use these sutures and should return them to the point of purchase or contact the manufacturer for a refund or replacement.

The recalled product

Product: Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - 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 Sutures
Hazard: sterility-loss
packaging-defect
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 (4)

1) Lot - A9H0927Y Expiration Date - 2024-07-31
2) Lot - A9H1187Y Expiration Date - 2024-07-31
3) Lot - A9J0383Y Expiration Date - 2024-08-31
4) Lot - A9J0428Y Expiration Date - 2024-08-31

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.

See all 27 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · sterility loss