FDA Device recall Z-0568-2013
Medline Angio Drape Pack Radiology-LF
- FDA Device
- Class II
- terminated
- Published 2012-12-26
On 2012-12-26 the FDA classified a Class II recall of Medline Angio Drape Pack Radiology-LF by Medline Industries, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0568-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-08 |
| Published | 2012-12-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medline Industries |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Reorder #DYNJ35993D, lot numbers 12HD2126, exp. 5/31/2015; 12IB5014, exp. 7/31/2015 and 12JB8311, exp. 5/31/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0568-2013%22
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