Medtronic Recalls Polysorb Sutures Due to Potential Incomplete Seal
Medtronic is recalling specific Polysorb suture products because an incomplete inner package seal may cause the suture material to degrade prematurely.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a potential for premature degradation without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Medtronic is recalling specific lots of Polysorb suture products. The recall involves 478,465 units distributed worldwide, including the United States (including Puerto Rico) and various international markets such as Australia, Belgium, Canada, Chile, China, Israel, Italy, Japan, Korea, Mexico, Panama, Saudi Arabia, Singapore, and Turkey.
The reason for the recall is a potential for an incomplete seal on the inner package. This defect may result in the premature degradation of the suture material. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare providers and facilities should check their inventory for the specific item numbers and lot codes listed in the official recall notice. If affected products are found, they should be removed from use and returned to Medtronic or the authorized distributor according to the firm's instructions.
The recalled product
- Product
- Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60"
- Manufacturer
- Medtronic
- Category
- Medical Device — Sutures
- Affected units
- 478,465
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medtronic 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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