Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste ba

FDA device recall Z-0568-2013 · posted 2012-12-19 · Terminated

Recall details

Recalling firm

Medline Industries Inc

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 taken

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.

Root cause

Packaging

Status

Terminated

Product code

LRO

Quantity affected

105 packs

Distribution

Nationwide distribution: New York only.

Date initiated

2012-11-08

Date posted

2012-12-19

Date terminated

2012-12-20

Location

Mundelein, IL