Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resus
FDA device recall Z-1809-2015 · posted 2015-06-24 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The intake port may be blocked which can cause the bag to fail to fill.
- Action taken
- 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 610-378-0131.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- BTM
- Quantity affected
- 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 Ric
- Date initiated
- 2015-05-14
- Date posted
- 2015-06-24
- Date terminated
- 2024-05-13
- Location
- Research Triangle Park, NC
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR (K964719) | Hudson Respiratory Care, Inc. | 1997-02-21 |