Z-0870-2013Class II

MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures...

Name: Z-0870-2013 MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures...
Creator: Medrad Inc
Published: 2012-11-05
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2012-11-05 / Terminated / root cause: packaging

FDA source

Medrad Inc began a recall of MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use... on 2012-11-05. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0870-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Posted: 2013-02-21
Terminated: 2015-03-10
Recalling firm: Medrad, Inc.
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.
Product code: DXT Injector And Syringe, Angiographic
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.
Root cause tag: packaging
FDA root cause: Packaging
Action: Medrad sent a Recall letter dated November 5, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were instructed to review their inventory and quarantine any packages with an expiration date prior to April, 2017. Customers were also given the option of conducting a visual inspection on site to determine if the product should be returned. Alternatively, the customer has the option of returning the affected product. If the customer has affected product, they are instructed to contact Medrad Customer Support to make arrangements for the return and replacement of the product. For further questions please call our Customer Support Team at 1-877-229-3767.
Quantity in commerce: 832,175
Distribution: Worldwide Distribution including USA nationwide.
Product codes and lots: 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, D93561, D101311, D101911, D111201, D112411A, D120171A, DA80231, DA90631, D93631, DA101441, DA101931, D111221, D112421, D120181, DA80241, D90821, DA93631, D101441, D101931, D111231, D112421A, D120311, D80281, DA90831, DA100141, D101461, D101951, D111241, D112431, D120311A, D80391, D90981, D100151, DA101461, DA101951, D111261, D112431A, D120321, DA80561, D91031, D100181, D101471, D101971, D111261A, D112441, D120321A, D80631, DA91041, DA100191, DA101481, D102111, D111291, D112441A, D120331, DA80641, DA91061, DA100321, D101481, D102141, D111291A, D112481, D120341, D80871, D91071, D100331, DA101511, DA102141, D111301, D112481A, D120371, D80981, D91181, DA100341, D101511, D102151, D111301A, D112491, D120371A, DA81281, D91191, D100351, D101531, DA102151, D111311, D112501, D120381, DA81421, D91281, DA100461, DA101531, D102351, D111311A, D112621, D120381A, D81471, D91331, D100561, D101541, DA102351, D111321, D112621A, D120391, D81541, D91351, D100671, D101551, D102811, D111321A, D112631, D120451, DA81821, D91381, DA100671, DA101551, D102821, D111361, D112631A, D120511, D81971, D91561, DA100691, D101581, D102921, D120861A, D112641, D120521, D81991, D91901, D100691, DA101581, D103361, D111351, D112721, D120521A, DA82031, D92061, D100711, D101591, D103401, D111371, D112791, D120531, D82131, D92091, DA100711, DA101601, D103481, D111371A, D113071, D120541, D82141, D92111, DA100741, D101601, D103631, D111381, D113081, D120541A, D82171, D120881, D100751, D101611, D103611, D111711, D113111, D120551, D82181, D92501, D101021, D101621, D103571, D111721, D113111A, D120591, D82191, D92521, DA101021, DA101621, D103621, D111731, D113291, D120601, DA82201, DA92781, D101031, D101631, D110181, D111751, D113291A, D120671, D120881A, D92791, D101041, D101651, D110191, D111861, D113321, D120671A, D82241, D93081, DA101041, DA101651, D110321, D111871, D113321A, D120681, DA82251, D93091, D101061, D101661, D110331, D111891, D113331, D120681A, D82671, D93101, DA101061, D101671, D110351, D111921, D113331A, D120691, D82701, D93111, D101071, DA101671, D110541, D111921A, D113341, and D120721.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0870-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0870-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-21

Product code DXT

K050456Class IIMedrad Avanta Fluid Management Injection SystemMedrad, Inc. / cleared 2005-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)