Teleflex Medical is recalling 9,333 units of its Hudson RCI Lifesaver Single Patient Use manual ventilator, according to the FDA’s recall database.
Recall info
Product name: Lifesaver Single Patient Use Manual Resuscitator
Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.
Manufacturer Reason for Recall: The intake port may be blocked which can cause the bag to fail to fill.
FDA Determined Cause: Nonconforming Material/Component
Action: Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated May 14, 2015, to all consignees asking them to immediately discontinue distribution and quarantine the recalled product. The letter also requested a sub-recall of the product. The recall letter also included a response form which is to be returned to Teleflex by emailing it to [email protected] or fax it to 1-855-419-8507, Attn: Customer Service. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.
