Reported Aug 28, 2019 · Terminated
PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery…
Pro-Dex Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pro-Dex Inc · 2361 McGaw Ave · Irvine, CA · 92614-5831
Is this the product you have?
- PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40
- Pouches - PDBP-040-2 Product Usage-The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Product as published PDBP-040-2(40ct PDBP-001-2) which are 40 count batteries. Lot(s): K098N (61900), K0B3F (62625) K098N and K0B3F are Pro-Dex — lot numbers. 61900 and 62625 are the contract packager's — lot numbers UDI Code: (01) 0 0860540 00025 6 - Amount recalled
- 68 cases of 40 batteries = 2,720 individual batteries
Where it was sold
Why it was recalled
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
This product could cause temporary or reversible health problems — stop using it.
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