KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin Ma

FDA device recall Z-0280-2025 · posted 2024-10-31 · Open, Classified

Recall details

Recalling firm

Pro-Dex Inc

Reason for recall

The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.

Action taken

On 9/23/24, an "URGENT" recall notice was emailed to the customer informing of the product, issue, risk and actions to be taken. Customers were instructed to do the following: 1) Please immediately cease distribution and use of these lots. Inventory and distribution records should be evaluated to ensure that affected product is removed from any potential point of use. 2) Product should be returned to the recalling firm. 3) The Recall Acknowledgement and Return Form should be completed and returned via email to Recall@Pro-Dex.com or FAX 949.769.3281. Questions or concerns can be directed to the firm at 949-769-3200 or Recall@Pro-Dex.com

Root cause

Component design/selection

Status

Open, Classified

Product code

MOQ

Quantity affected

2000

Distribution

US distribution to FL only.

Date initiated

2024-09-23

Date posted

2024-10-31

Location

Irvine, CA