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FDA device recall Z-2036-2012 · posted 2012-07-19 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, the alarm will not sound and could cause a potential delay in patient treatment.

Action taken

Teleflex sent Urgent Medical Device Notification letters dated June 12, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were instructed to complete the enclosed Acknowledgement Form and return per the instructions provided. Once the form is received, Teleflex Medial will schedule for a technician to come to their facility and exchange the affected product. For questions call your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Device Design

Status

Terminated

Product code

BTT

Quantity affected

14,794 each

Distribution

Worldwide Distribution - U.S. (nationwide) and the countries of Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan and UK.

Date initiated

2012-06-12

Date posted

2012-07-19

Date terminated

2014-01-28

Location

Research Triangle Park, NC

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