Recall Z-1809-2015 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Teleflex Medical
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.
| Date | Jun 24, 2015 (initiated May 14, 2015) |
| Status | Terminated |
| Reason | The intake port may be blocked which can cause the bag to fail to fill. |
| Root 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 recall@teleflex.com 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 |
| Quantity | 9,333 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IA, KS, LA, MA, MI, MN, MS, MO, NE, NH, NY, NC, OH, OK, PA, RI, SD, TN, TX, VA, WA, including Puerto Rico and the countries of Australia, Bahamas, Canada, Guatemala, and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964719 | HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR Hudson Respiratory Care, Inc., Feb 21, 1997 |