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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Medline Angio Drape Pack Radiology-LF		see related information
Date Posted December 19, 2012
Recall Number Z-0568-2013
Product 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.
Code Information Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015
Recalling Firm/
Manufacturer		 Medline Industries Inc
1 Medline Pl
Mundelein, Illinois 60060
Reason for
Recall		 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.
Action The firm, Medline Industries, Inc., telephoned the consignee/customer on November 8, 2012. The phone call informed the customer of the product, problem and actions to be taken. The customer was instructed to inform the staff at the facility not to use the pack until it had been reworked to replace the non-sterile waste bag with the sterile equivalent. It was also noted that the product does not need to be returned as it is being replaced directly at the facility. If you have any question call 847-837-2759 or email lsimmons@medline.com.
Quantity in Commerce 105 packs
Distribution Nationwide distribution: New York only.
 
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