The Recall Desk
ModerateFDA (Devices)·Z-1612-2022·Announced 2022-08-31

Fischer Cone Biopsy Excisor recalled for potential temperature damage

McKesson is recalling Fischer Cone Biopsy Excisor Model 900-157 units because temperature excursions during storage may have compromised product effectiveness.

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, injuries, or hospitalizations. The hazard is theoretical—temperature exposure 'may have' impacted effectiveness, but actual product failures or patient harm have not been reported.

Plain-English summary

McKesson Medical-Surgical Inc. is recalling the Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (Model 900-157) due to potential temperature damage prior to delivery.

The affected units were exposed to temperature excursions between June and August 2021, prior to shipment. These higher temperatures may have impacted the product's effectiveness and reliability during clinical use.

All units received between June 1, 2021 and September 30, 2021 are affected. The product was distributed nationwide in the United States. Each affected box contains 5 units.

Healthcare facilities and clinicians who received affected units should discontinue use and contact their McKesson representative regarding replacement or instructions for return.

The recalled product

Product
Fischer Cone Biopsy Excisor EXCISOR, CONE FISCHER BIOPSY WD ANGL SM (5/BX) Model Number: 900-157
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
  • temperature-exposure
  • product-effectiveness

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 (2)

  • GTIN: 00888937003765
  • 20888937003769

Distribution

Distributed nationwide across the United States.