Recall Z-2340-2019 ยท GEY Motor, Surgical Instrument, Ac-Powered
Pro-Dex Inc
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 t
| Date | Sep 25, 2018 |
| Status | Terminated |
| Reason | Visual particulates within a battery Tyvek pouch. The battery is provided sterile for use with surgical drivers. |
| Root cause | Under Investigation by firm |
| Action | On 09/25/2018, the firm sent an "URGENT" notification to customers via email and followed up with a (USPS) letter on 09/26/2018 informing them that certain lots of sterile batteries may have visible particulates within the battery Tyvek pouch. Customers were advised to 1) "immediately cease distribution and use of these lots, and 2) Inventory and distribution records should be evaluated immediately to ensure that affected product is removed from any potential point of use". Customers are instructed to return products to: Returns Department (Recall complaint C18-061 Pro-Dex, Inc. 2361 McGaw A |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.