Surgical Screwdriver Battery Pack Recalled for Foreign Material Contamination
Pro-Dex Inc is recalling KLS Martin battery packs for surgical drivers distributed in Florida because the sterile packaging may contain Tyvek shavings that could compromise device 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 a sterile medical device with foreign material contamination; however, no illnesses, injuries, or hospitalizations have been reported. The recall meets the criteria for a risk-of-harm product where injury has not yet been documented.
Plain-English summary
Pro-Dex Inc is recalling the KLS Martin Battery Pack (REF: KLS BP2 001 and KLS BP2 040) used with the KLS Martin MaxDriver 2.0 surgical driver. These sterile battery packs are used in surgical applications. Approximately 2,000 units were distributed in Florida.
The sterile packaging of these battery packs may contain Tyvek shavings. These are synthetic fibers from packaging material that should not be present inside a sterile device package.
Healthcare facilities in Florida that have received these battery packs should stop using them and contact Pro-Dex Inc for replacement or removal instructions.
The recalled product
- Product
- KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
- Manufacturer
- Pro-Dex Inc
- Affected units
- 2,000
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 (2)
- Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122
- KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115
Distribution
Distributed in 1 state:
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