Reported Dec 26, 2012 · Terminated
Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste…
Medline Industries Inc.
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: Medline Industries Inc · 1 Medline Pl · Mundelein, IL · 60060
Is this the product you have?
- Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional Radiology Department; Packaged for Medline Industries, Inc.; Reorder #DYNJ35993D This custom pack includes components necessary for a specific procedure.
- Lot codes and dates
Reorder #DYNJ35993Dlot numbers 12HD2126exp. 5/31/201512IB5014exp. 7/31/2015 and 12JB8311exp. 5/31/2015
- Amount recalled
- 105 packs
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- NY
Why it was recalled
The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in its own packaging. The product was not labeled or identified as sterile, but was assumed to be sterile by the customer.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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