Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and I

FDA device recall Z-1887-2013 · posted 2013-08-07 · Terminated

Recall details

Recalling firm

Cordis Corporation

Reason for recall

Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.

Action taken

Cordis Corporation sent an "URGENT Medical Device Correction" notification to their consignees in the US by letter dated April 3, 2013 and an e-mail was sent to the Canadian consignees. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to read the description and recommendations sections carefully, then sign and return the enclosed Acknowledgement Form directly to Cordis to their fax number(908) 429-8287 or Scan and e-mail to MiamiQA@crdus.jnj.com. The letter states to pass on the notice to anyone in the consignees' facilities that need to be informed. Additionally, the notification request consignees to maintain awareness of this notification until the information has been incorporated in the Cordis OPTEASE Vena Cava Filter labeling. For questions related to the issue contact Cordis Endovascular Medical Information Line 877-338-4235.

Root cause

Labeling design

Status

Terminated

Product code

DTK

Quantity affected

33,000 units

Distribution

Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, Ny, OH, OK, OR, PA,

Date initiated

2013-03-29

Date posted

2013-08-07

Date terminated

2014-10-27

Location

Miami Lakes, FL

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