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U.S. Department of Health and Human Services

Class 2 Device Recall KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040

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  Class 2 Device Recall KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 see related information
Date Initiated by Firm February 15, 2023
Date Posted July 05, 2023
Recall Status1 Open3, Classified
Recall Number Z-2098-2023
Recall Event ID 92493
Product Classification Motor, surgical instrument, ac-powered - Product Code GEY
Product KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
Code Information REF: KLS-BP-001/KLS-BP-040, UDI-DI: 00862377000140, Lot: K0M6U, Expiration: 8/31/2024
Recalling Firm/
Manufacturer		 Pro-Dex Inc
2361 McGaw Ave
Irvine CA 92614-5831
For Additional Information Contact
800-562-6204
Manufacturer Reason
for Recall		 Battery packs used in surgical procedures where a surgeon uses a powered screwdriver and a right-angle attachment have switched manufacturing and expiration dates on sterile pouch labels, so batteries will appear to be prematurely expired.
FDA Determined
Cause 2		 Error in labeling
Action On 2/15/23, a recall notice was sent to a customer asking them to cease distribution and return affected product to the recalling firm. Questions can be directed to 949-769-3200.
Quantity in Commerce 2000
Distribution US: FL
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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