HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate liquids or semisolids from a patie

FDA device recall Z-2369-2015 · posted 2015-08-20 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

The double swivel connector may crack or separate on the endobronchial tube.

Action taken

Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated June 1, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were directed to contact any customers who had received the product included within the scope of this recall. Customers were directed to immediately discontinue use and quarantine any products with the referenced catalog numbers and lot numbers listed in the notification. Additionally, customers were asked to return any affected product together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

CBI

Quantity affected

188,195 total units

Distribution

Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.

Date initiated

2015-06-01

Date posted

2015-08-20

Date terminated

2018-04-16

Location

Research Triangle Park, NC