Skin markers: a. IZI MEDICAL PRODUCTS LLC recall
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…
Why was Skin markers: a. IZI MEDICAL PRODUCTS LLC 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: a. 00815212020766. b. unknown
- 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…
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Quantity
- a. 2 bx b. 3 bx
- Distribution
- US Nationwide distribution.
- Recall date
- October 5, 2022
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)