PlainRecalls
FDA Devices Low Class III Ongoing

Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140

Reported: October 5, 2022 Initiated: May 25, 2022 #Z-1802-2022

Product Description

Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140

Reason for Recall

Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

Details

Units Affected
13
Distribution
US Nationwide distribution.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Medical Monofilament Manufacturing MONOFILIMENT TEST, SENSORY F/FOOT 10GM (40/PK) Model Number: AM140. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 13.
Why was this product recalled?
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 5, 2022. Severity: Low. Recall number: Z-1802-2022.