MEDRAD Hand Controller Sheath — Class II medical device recall Z-0870-2013
Terminated recall by Medrad Inc, reported 2013-02-27, distributed nationwide. The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath pac
| Recall number | Z-0870-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medrad Inc, Warrendale, PA, United States |
| Recall initiated | 2012-11-05 |
| Classified | 2013-02-21 |
| Reported by FDA | 2013-02-27 |
| Terminated | 2015-03-10 |
| Distributed | Nationwide (US) |
| Quantity | 832,175 |
| Reason classes | sterility, packaging |
| Lot numbers | D100151, D100181, D100331, D100351, D100561, D100671, D100691, D100711, D100751, D101021, D101031, D101041, D101061, D101071, D101091, D101101, D101111, D101121, D101131, D101171, D101301, D101311, D101441, D101461, D101471, D101481, D101511, D101531, D101541, D101551, D101581, D101591, D101601, D101611, D101621, D101631, D101641, D101651, D101661, D101671 and 295 more |
| Model numbers | 500, HCS/3010903 |
Product
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.
Reason for recall
The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.
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-0870-2013. 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.