Medline Angio Drape Pack Radiology-LF — Class II medical device recall Z-0568-2013
Terminated recall by Medline Industries Inc, reported 2012-12-26, distributed nationwide. The non-sterile Waste Bag component in the custom pack was attached to the outside of the pack in its own pack
| Recall number | Z-0568-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Mundelein, IL, United States |
| Recall initiated | 2012-11-08 |
| Classified | 2012-12-19 |
| Reported by FDA | 2012-12-26 |
| Terminated | 2012-12-20 |
| Distributed | Nationwide (US) |
| Quantity | 105 packages |
| Reason classes | labeling, sterility |
| Lot numbers | 12HD2126, 12IB5014, 12JB8311 |
| Expiration dates | 2015-05-31, 2015-07-31 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0568-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.