Recall Z-0870-2013
Medrad Inc · initiated November 5, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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…
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.
FDA-determined cause: Packaging
Action taken
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.
Details
- Recall number
- Z-0870-2013
- Initiated
- November 5, 2012
- Posted by FDA
- February 21, 2013
- Terminated
- March 10, 2015
- Product code
- DXT – Injector And Syringe, Angiographic
- Quantity
- 832,175
- Distribution
- Worldwide Distribution including USA nationwide.
- Recalling firm
- Medrad Inc, Warrendale, PA