Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2340-2019 — 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.

U.S. FDA — Device Enforcement · United States · 2018-09-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2340-2019
Date of alert: 2018-09-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Pro-Dex Inc
Product category: device
Product type: Devices

Reported risk: Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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