Z-1028-2020 Class II Terminated
FDA device recall Z-1028-2020 was initiated by Cardinal Health on January 11, 2020 and is designated Class II. Reason for recall: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination. The recall status is terminated (terminated January 19, 2023). Affected quantity: 7,659,634 total units.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- January 11, 2020
- Termination Date
- January 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,659,634 total units
Product Description
AAMI 3 NON-REINF SURGICAL GOWN XXL, Item Code 9575
Reason for Recall
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
Distribution Pattern
Worldwide distribution US Nationwide including Puerto Rico and Guam, United Arab Emirates, Australia, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Israel, Mexico, Oman, Panama, Philippines, and Saudi Arabia.
Code Information
Lot Numbers: XXXXJXXX Single-Sterile Lot Format: YYMRJXXX Where: YY Last two digits of the year ( 18 or '19) M Month in alpha code " If made in 2018 o J for September o K for October o L for November OR o M for December " If made in 2019, any value is affected R Product revision or suffix P Facility code is letter J XXX Sequential Number - Monthly reset OR Bulk Non-Sterile Lot Format: XXXYRPQ Where: XXX Elapsed days of year " " If made in 2018, 244 or greater is affected OR " " If made in 2019, any value is affected; see below for year made identifier Y Last character of year gown was made (2018 or 2019) R Product Revision P Facility code is letter J Q Plant shift identifier; this identifier was added during the affected time period and therefore older product may not contain this digit in the lot number