Medtronic Recalls Custom Suture Packs Due to Potential Seal Defects
Medtronic is recalling custom suture packs because an incomplete inner package seal may cause the suture material to degrade prematurely.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when the defect involves structural integrity that could lead to significant injury or failure of the medical device.
Plain-English summary
Medtronic is recalling Custom Suture Packs, specifically Item Numbers US1540 and US1614. The recall involves a total of 478,465 units. The products were distributed worldwide, including the United States (including Puerto Rico) and countries such as Australia, Belgium, Canada, Chile, China, Israel, Italy, Japan, South Korea, Mexico, Panama, Saudi Arabia, Singapore, and Turkey.
The recall was initiated due to a potential for an incomplete seal on the inner package. This defect may result in the premature degradation of the suture material. The agency has classified this as a Class II recall.
Healthcare providers and facilities should check their inventory for the affected item numbers and stop using any units that may be compromised. Consumers are advised to contact Medtronic for further instructions regarding the return or replacement of these products.
The recalled product
- Product
- CUSTOM SUTURE PACK; Item Number: US1540 and US1614
- Manufacturer
- Medtronic
- Affected units
- 478,465
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)
- A5C1345X A5E0919X
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.
See all 8 products in this recall →Related recalls
Same manufacturer · Medtronic
See all →- HighMedtronic Recalls BIOSYN Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
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- ModerateMedtronic Recalls Polysorb Sutures Due to Potential Incomplete Seal
FDA (Devices) · 2017-06-21
- HighMedtronic Recalls Best Practice Kits Due to Potential Seal Defects
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