Z-1801-2022 Class III Ongoing
FDA device recall Z-1801-2022 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on May 25, 2022 and is designated Class III. 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… The recall status is ongoing. Affected quantity: a. 2 bx b. 3 bx.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 5, 2022
- Initiation Date
- May 25, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a. 2 bx b. 3 bx
Product Description
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.
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 Pattern
US Nationwide distribution.
Code Information
GTIN: a. 00815212020766. b. unknown
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1801-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026