Z-0568-2013 Class II Terminated
FDA device recall Z-0568-2013 was initiated by Medline Industries Inc on Nov 8, 2012 and is designated Class II. 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… The recall status is terminated (terminated Dec 20, 2012). Affected quantity: 105 packs.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2012
- Initiation Date
- Nov 8, 2012
- Termination Date
- Dec 20, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105 packs
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.
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.
Distribution Pattern
Nationwide distribution: New York only.
Code Information
Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0568-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026