—#114684

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.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015

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.

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060

Distribution

Distribution pattern: Nationwide distribution: New York only.

Timeline

Recall initiated: 2012-11-08
Posted by FDA: 2012-12-19
Terminated: 2012-12-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114684. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.