Brasseler K-WIRE surgical instruments recalled for unsealed packaging
Brasseler USA is recalling 231 units of K-WIRE Double Trocar Smooth surgical instruments due to unsealed packaging 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: This is a Class II recall of surgical instruments with unsealed packaging. While no illnesses have been reported, the potential for contamination of sterile surgical instruments presents a risk of harm to patients. This meets the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Brasseler USA, Medical L.L.C. is recalling one lot of K-WIRE, Double Trocar Smooth surgical instruments (REF KM172-26-35S, Lot Code NV1MX) that was distributed with unsealed packaging.
These surgical instruments require appropriate packaging to maintain sterility. Unsealed packaging may allow contamination of the instruments prior to use, potentially compromising their safety.
The recalled lot includes 231 units distributed nationwide to medical facilities in Ohio, Michigan, Arizona, Florida, California, Tennessee, Texas, South Carolina, Pennsylvania, Illinois, and Idaho. No illnesses or injuries have been reported.
Healthcare facilities that received affected units should immediately quarantine them and contact Brasseler USA for instructions on return or replacement.
The recalled product
- Product
- Brasseler USA, K-WIRE, Double Trocar Smooth, REF KM172-26-35S
- Manufacturer
- Brasseler USA, Medical L.L.C.
- Affected units
- 231
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)
- UDI (01)00887919491033(17)260719(10)NV1MX Lot Code NV1MX
Distribution
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