Aami 3 Nonreinf Surg Gown 3xl BNS recall: Particulate Matter
AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
Why was Aami 3 Nonreinf Surg Gown 3xl BNS recalled?
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
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
- Product
- AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
- Recalling firm
- Cardinal Health
- Quantity
- 7,659,634 total units
- Distribution
- 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.
- Recall date
- February 12, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)