Reported Feb 12, 2020 · Terminated
ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
Cardinal Health
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health · 1350 Bridge Dr · Waukegan, IL · 60085-6306
Is this the product you have?
ROYALSILK 3XLARGE/XLONGGown. Item Code 95998
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 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 2 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 3 lot number - Amount recalled
- 7,659,634 total units
This recall covers 39 products
The agency filed one notice per product. You are reading one of them; the other 38 are below.
26 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Cardinal Health recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.