FDAFDA · Food and drugs·Recall number Z-0280-2025
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
Published November 6, 2024 · Recall initiated: September 23, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pro-Dex Inc
- Distributor
- US distribution to FL only.
- Lot
- Lot: REF/UDI-DI: K0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129. KLS-SD-2000/00856482008115
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.