Z-0568-2013Class II

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

Name: Z-0568-2013 Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including...
Creator: Medline Industries Inc
Published: 2012-11-08
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2012-11-08 / Terminated / root cause: packaging

FDA source

Medline Industries Inc began a recall of Medline Angio Drape Pack Radiology-LF; a sterile custom single patient prescription procedure pack, including a waste bag, for use by the Interventional... on 2012-11-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0568-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-08
Posted: 2012-12-19
Terminated: 2012-12-20
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: LRO General Surgery Tray
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.
Root cause tag: packaging
FDA root cause: 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 [email protected].
Quantity in commerce: 105 packs
Distribution: Nationwide distribution: New York only.
Product codes and lots: Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0568-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0568-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-19

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)