KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxD
FDA device recall Z-2098-2023 · posted 2023-07-05 · Open, Classified
Recall details
- Recalling firm
- Pro-Dex Inc
- 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.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- GEY
- Quantity affected
- 2000
- Distribution
- US: FL
- Date initiated
- 2023-02-15
- Date posted
- 2023-07-05
- Location
- Irvine, CA
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