Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005. b. SKIN MARKER MAMMO BB2.0 100B - Mammography Skin Marker Catalog # SDM-BB20.
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling two types of skin markers distributed nationwide between June 1, 2021 and September 30, 2021: IZI Medical Products LLC Multi-Modality Markers (Catalog #MM3005) and Skin Marker Mammo BB2.0. The recall was issued because these products were exposed to higher-than-appropriate temperatures at a facility between June and August 2021 prior to delivery, which may have impacted their effectiveness. However, the manufacturer determined that this specific temperature deviation is not likely to cause adverse health consequences.
The record 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. 2 bx b. 3 bx Lot/code info: GTIN: a. 00815212020766. b. unknown
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.