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

FDA device recall Z-0870-2013 · posted 2013-02-21 · Terminated

Recall details

Recalling firm

Medrad Inc

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.

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.

Root cause

Packaging

Status

Terminated

Product code

DXT

Quantity affected

832,175

Distribution

Worldwide Distribution including USA nationwide.

Date initiated

2012-11-05

Date posted

2013-02-21

Date terminated

2015-03-10

Location

Warrendale, PA

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