Medline Industries Inc: Medical Device Recall in 2012 - (Recall #: Z-0568-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 8, 2012

Date Posted: December 26, 2012

Recall Number: Z-0568-2013

Event ID: 63739

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.

Status: Terminated

Product Quantity: 105 packs

Code Information:

Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015

Distribution Pattern:

Nationwide distribution: New York only.

Voluntary or Mandated:

Voluntary: Firm initiated