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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 Device Recall Medline Angio Drape Pack RadiologyLF see related information
Date Initiated by Firm November 08, 2012
Date Posted December 19, 2012
Recall Status1 Terminated 3 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/
Medline Industries Inc
1 Medline Pl
Mundelein IL 60060
For Additional Information Contact
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
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.