Absorbent dressings. a. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/4"X5YDSSTR LF (12 MGM61 61- Catalog #61-59120. b. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1/2"X5YDSSTR LF (12/CS) MGM61 Catalog #61-59220. c. DERMA SCIENCES, INC. McKesson PACKING STRIP, PLAIN 1"X5YDS STR LF (12/
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling absorbent dressing packing strips (Derma Sciences, Inc. products, catalog #61-59120 and related items) distributed nationwide between June 1, 2021 and September 30, 2021. The recall was initiated because the products were exposed to higher temperatures during storage at a facility between June and August 2021, which may have affected product effectiveness. However, the manufacturer states that this specific temperature deviation is not likely to cause adverse health consequences.
The recall affects multiple lot numbers identified by specific GTINs and involves quantities across various package sizes. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide distribution. Quantity: a. 56.083 b. 472 btl c. 103 btl d. 133.5 bx e. 127.6 bx f. 14 bx Lot/code info: GTIN: a. 10612479136066, 40612479136074. b. 10612479136080, 40612479136098. c. 10612479136103; 40612479136111. d. 10381780486978, 30381780486972. e. 00809958081907, 00809958081914. f. 30381780491778, 10381780491774
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.