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.
Reported: July 1, 2015 Initiated: May 14, 2015 #Z-1809-2015
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.
Details
- Recalling Firm
- Teleflex Medical
- Units 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 Rico and the countries of Australia, Bahamas, Canada, Guatemala, and Mexico.
- Location
- Research Triangle Park, NC
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Teleflex Medical. Units affected: 9,333 units.
Why was this product recalled? ▼
The intake port may be blocked which can cause the bag to fail to fill.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2015. Severity: Critical. Recall number: Z-1809-2015.
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