The Recall Desk
ModerateFDA (Devices)·Z-2098-2023·Announced 2023-07-12

KLS Martin Battery Packs Recalled for Switched Expiration Date Labels

Pro-Dex Inc recalls KLS Martin Battery Packs used in surgical screwdrivers due to manufacturing and expiration dates being reversed on sterile pouch labels, causing batteries to appear prematurely expired.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a labeling error where manufacturing and expiration dates are reversed on sterile pouches, classified as a minor labeling error. Without reported incidents and with the hazard being primarily administrative in nature, this meets the criteria for Moderate severity.

Plain-English summary

The KLS Martin Battery Pack (REF: KLS BP 001 and KLS BP 040) is used with the KLS Martin MaxDriver, a powered surgical screwdriver with a right-angle attachment employed in surgical procedures. The recalled product is from lot K0M6U.

Pro-Dex Inc has issued a recall due to a labeling error on the sterile pouch labels. The manufacturing and expiration dates have been switched, which causes the batteries to appear prematurely expired.

Approximately 2,000 units were distributed in Florida. The reversed dates on the labels may result in confusion about the batteries' actual usability status.

The recalled product

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
Manufacturer
Pro-Dex Inc
Hazard
  • mis-labeling
  • expiration-date-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • REF: KLS-BP-001/KLS-BP-040
  • UDI-DI: 00862377000140
  • Lot: K0M6U
  • Expiration: 8/31/2024

Distribution

Distributed in 1 state:

  • FL