Recall Z-1804-2022— Mckesson Medical-Surgical Inc. Corporate Office
Class III · Ongoing
Class III FDA medical device recall by Mckesson Medical-Surgical Inc. Corporate Office, initiated 2022-05-25. FDA's recall record names no specific 510(k) clearance for this event. Product: a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454. Reason: 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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences..
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2022-05-25
- Firm location
- Richmond, VA, United States
Product description
a. Dynarex DRESSING, UNNA BOOT 3"X10' (12/CS), Catalog # 3453. b. Dynarex DRESSING, UNNA BOOT BANDAGE 4"X10' (12/CS) Catalog # 3454
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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
Data sourced from openFDA. This site is unofficial and independent of the FDA.