FDAFDA · Food and drugs·Recall number Z-1012-2020
AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
Published February 12, 2020 · Recall initiated: January 11, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health
- Distributor
- 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.
- Lot
- Lot Numbers: XXXXXJ or XXXXXJX 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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