The Recall Desk
ModerateFDA (Devices)·Z-1801-2022·Announced 2022-10-05

Skin markers recalled due to storage temperature exposure

Mckesson Medical-Surgical Inc. recalls skin markers used in medical imaging that may have been exposed to excessive temperatures during storage prior to delivery. Affected units were received between June and September 2021.

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 a Class III device recall with a precautionary basis: no illnesses or injuries have been reported, and the FDA explicitly states the temperature deviation is 'not likely to cause adverse health consequences.' The hazard—potential product effectiveness degradation—is theoretical, placing this in the 'voluntary precautionary recall' category per the rubric.

Plain-English summary

Mckesson Medical-Surgical Inc. is recalling two types of skin markers used in medical imaging procedures: the IZI Medical Products Multi-Modality Markers (Skin Marker Radio 1.5mm, Catalog #MM3005) and the Skin Marker Mammo BB2.0 (Catalog #SDM-BB20). These markers are placed on patient skin to identify anatomical landmarks during imaging studies such as mammography and general radiology.

The recall was initiated because the markers experienced temperature excursions—temperatures higher than the recommended storage conditions—between June and August 2021 prior to delivery. Skin markers received by customers between June 1, 2021 and September 30, 2021 are affected. Exposure to elevated temperatures during this period could potentially impact the markers' performance and effectiveness.

According to the FDA, this device with this specific storage temperature deviation is not likely to cause adverse health consequences. Patients and healthcare providers who have used or may use affected markers should be aware of this recall. If you have concerns about whether specific markers are affected by this temperature deviation, contact Mckesson Medical-Surgical Inc.

The recalled product

Product
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.
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Medical Device — Imaging Marker
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 (1)

  • GTIN: a. 00815212020766. b. unknown

Distribution

Distributed nationwide across the United States.

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