FDAFDA · Food and drugs·Recall number Z-0568-2013
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.
Published December 26, 2012 · Recall initiated: November 8, 2012
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 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medline Industries Inc
- Distributor
- Nationwide distribution: New York only.
- Lot
- Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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