FDA Device recall Z-0870-2013
MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures
- FDA Device
- Class II
- terminated
- Published 2013-02-27
On 2013-02-27 the FDA classified a Class II recall of MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures by Medrad, citing 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 access….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0870-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-05 |
| Published | 2013-02-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medrad |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog number AVA 500 HCS/3010903 - Lot numbers D72211, DA82711, DA93131, D101091, D101681, D110591, D111961, D113341A…Catalog number AVA 500 HCS/3010903 - Lot numbers D72211, DA82711, DA93131, D101091, D101681, D110591, D111961, D113341A, D120731, D101641, D82741, D93131, DA101091, DA101691, D110601, D111991, D113351, D120831A, D72251, D83011, D93151, D101101, D101701, D110611, D112061, D113351A, D120741, D72261, DA83021, DA93151, DA101101, DA101721, D110621, D112131, D113461, D120761, D72281, DA83031, DA93221, D101111, D101721, D110631, D112131A, D113461A, D120771, D72291, D83041, D93231, DA101111, D101731, D110661, D112341, D113471, D120831, D72651, DA83121, D93411, D101121, D101741, D110731, D112341A, D113471A, D120861, D72671, D83151, DA93411, DA101121, D101861, D110741, D112351, D113491, DA72681, D83651, D93421, D101131, DA101861, D110751, D112351A, D113501, DA72691, D90021, DA93421, DA101131, D101881, D110871, D112361, D120161, D72751, D90541, D93431, D101171, DA101881, D110881, D112361A, D120161A, D120891, D90561, DA93431, D101301, DA101901, D110901, D112411, D120171, D80221, D90611, D9 |
|---|
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-0870-2013%22
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