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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Angio Drape Pack RadiologyLF

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 Class 2 Recall
Medline Angio Drape Pack RadiologyLF
see related information
Date Posted December 19, 2012
Recall Status1 Terminated on December 20, 2012
Recall Number Z-0568-2013
Recall Event ID 63739
Product Classification General Surgery Tray (Kit) - Product Code LRO
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
Manufacturer 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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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