PRO-DEX Surgical Driver Battery Pack PDBP-001 Series recall: Particulate Matter
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…
Why was PRO-DEX Surgical Driver Battery Pack PDBP-001 Series recalled?
Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
PDBP-001 Series Model: 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
- Product
- 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…
- Recalling firm
- Pro-Dex Inc
- Quantity
- 68 cases of 40 batteries = 2,720 individual batteries
- Distribution
- Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.
- Recall date
- August 28, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)