ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 7.0, Rx only, Product Usage:

FDA device recall Z-0959-2014 · posted 2014-02-21 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

The tracheal tube can kink during patient use.

Action taken

Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated January 6, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately discontinue use and quarantine any affected product. Return the product by completing the enclosed Recall Ackknowledgment Form and fax it to 1-866-804-9881, Attn: Customer Service to receive a Return Goods Authorization (RGA) number and instructions for the return of the affected product to Teleflex Medical. Consignees with no affected stock, should also complete the enclosed Recall Acknowledgment Form and fax it to 1-866-804-9881. Consignees with questions were instructed to call 1-866-246-6990. For questions regarding this recall call 919-572-8014.

Root cause

Other

Status

Terminated

Product code

BTR

Quantity affected

190,871 each (148, 275 US)

Distribution

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Barbados, Buenos Aires, Bolivia, El Salvador, Mexico, Columbia, Chile, Costa Rica, Dominican Republic, Ecuador, Bar

Date initiated

2014-01-06

Date posted

2014-02-21

Date terminated

2016-06-17

Location

Research Triangle Park, NC

Related 510(k) clearances