Reported Oct 5, 2022 · Ongoing
Skin markers: a. IZI MEDICAL PRODUCTS LLC Multi-Modality Markers SKIN MARKER RADIO 1.5MM 50BX Catalog #MM3005. b. SKIN…
Mckesson Medical-Surgical Inc. Corporate Office
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mckesson Medical-Surgical Inc. Corporate Office · 9954 Maryland Drive · Richmond, VA · 23233
Is this the product you have?
- Skin markersa. 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
- Lot codes and dates
- GTINa. 00815212020766. b. unknown
- Amount recalled
- a. 2 bx b. 3 bx
This recall covers 23 products
The agency filed one notice per product. You are reading one of them; the other 22 are below.
10 more are in the archive.
Where it was sold
- Nationwide
Why it was 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. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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