TAUT ADAPt Balloon Open Access Port And Syringe 10/12mm x 100mm, REF 41244, Rx Only, Sterile, Teleflex Medical, Research

FDA device recall Z-1890-2010 · posted 2010-06-23 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

Balloon does not hold air or water once inflated.

Action taken

The firm, Teleflex Medical, sent an "Urgent Medical Device Recall" letter dated May 10, 2010 to customers The letter described the product, problem and action to be taken by the customers. They were instructed to return all of the affected product to Teleflex. Each distributor was instructed to forward the letter to their customers to retrieve relevant product from those locations. A second mailing to non-responding customers will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, email, or fax. A record of these contacts will be maintained. Affected products received by Teleflex Medical will be destroyed upon receipt. Records will be maintained accordingly. Teleflex Medical will communicate to FDA on the status of recall activities. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Other

Status

Terminated

Product code

GCJ

Quantity affected

366 eaches

Distribution

Worldwide distribution: USA including states of AR, CO, FL, GA, IL, IN, KY, MI, MN, MO, NC, NY, OR, PA, WI, WV and country of France.

Date initiated

2010-05-12

Date posted

2010-06-23

Date terminated

2010-10-27

Location

Durham, NC

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