Recall Z-1809-2015— Teleflex Medical
Class I · Terminated
Class I FDA medical device recall by Teleflex Medical, initiated 2015-05-14, terminated 2024-05-13. It names one FDA 510(k) clearance: K964719. Product: 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.. Reason: The intake port may be blocked which can cause the bag to fail to fill..
- Recalling firm
- Teleflex Medical
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-05-14
- Terminated
- 2024-05-13
- Firm location
- Research Triangle Park, NC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The intake port may be blocked which can cause the bag to fail to fill.
Data sourced from openFDA. This site is unofficial and independent of the FDA.