Device 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.
Z-1809-2015
Product summary
- Firm
- Teleflex Medical
- Event
- Event 71254
- Status
- Terminated
- Classification
- Class I
- Quantity
- 9,333 units
- Official record key
device-enforcement:Z-1809-2015
Official wording
Reason: The intake port may be blocked which can cause the bag to fail to fill.
Code information: Product Code 5361 - 6 Digit Lot No. 140514 - 4 Digit Lot No. 1420; 6 Digit Lot No. 140616 4 Digit Lot No. 1425, 6 Digit Lot No. 140617 4 Digit Lot No. 1425; 6 Digit Lot No. 140621 4 Digit Lot No. 1425; 6 Digit Lot No. 140806 4 Digit Lot No. 1432; 6 Digit Lot No. 141103 4 Digit Lot No. 1445; 6 Digit Lot 141117 - No. 4 Digit Lot No. 1447; 6 Digit Lot No. 141201- 4 Digit Lot No. 1449; 6 Digit Lot No. 141224 - 4 Digit Lot No. 1452; 6 Digit Lot No. 141227 - 4 Digit Lot No. 1452; 6 Digit Lot No. 150112 - 4 Digit Lot No. 1503; Product Code 5362 - 6 Digit Lot No. 140504 - 4 Digit Lot No. 1419; 6 Digit Lot No. 140515 - 4 Digit Lot No. 1420; 6 Digit Lot No. 140517 - 4 Digit Lot No. 1420; 6 Digit Lot No. 140617 - 4 Digit Lot No. 1425; 6 Digit Lot No. 140621 - 4 Digit Lot 1425; No. 6 Digit Lot No. 140812 - 4 Digit Lot No. 1433; 6 Digit Lot No. 140819 - 4 Digit Lot No. 1434; 6 Digit Lot No. 140823 - 4 Digit Lot No. 1434; 6 Digit Lot No. 140929 - 4 Digit Lot No. 1440; 6 Digit Lot No. 141110 - 4 Digit Lot No. 1446; 6 Digit Lot No. 141115 - 4 Digit Lot No. 1446; 6 Digit Lot No. 141201 - 4 Digit Lot No. 1449; 6 Digit Lot No. 141214 - 4 Digit Lot No.1451; 6 Digit Lot No. 150112 4 Digit Lot No. 1503; Product Code 5364 6 Digit Lot No. 140507 - 4 Digit Lot No. 1419; 6 Digit Lot No. 140508 4 Digit Lot No. 1419; 6 Digit Lot No. 140514 - 4 Digit Lot No. 1420; 6 Digit Lot No. 140608 - 4 Digit Lot No. 1424; 6 Digit Lot No. 140614 - 4 Digit Lot No. 1424; 6 Digit Lot No. 140623 - 4 Digit Lot No. 1426; 6 Digit Lot No. 14628 - 4 Digit Lot 1426 - No. 6 Digit Lot No. 140714 - 4 Digit Lot No. 1429; 6 Digit Lot No. 140719 - 4 Digit Lot No. 1429; 6 Digit Lot No. 14806 - 4 Digit Lot No. 1432; 6 Digit Lot No. 140809 4 Digit Lot No. 1432; Product Code 5466 6 Digit Lot No. 140520 - 4 Digit Lot No. 1421; 6 Digit Lot No. 140923 - 4 Digit Lot No. 1439; 6 Digit Lot No. 140924 - 4 Digit Lot No. 1439; Product Code 45362 - 6 Digit Lot No. 140317 - 4 Digit Lot No. 1412; 6 Digit Lot No. 140630 - 4 Digit Lot No. 1427; 6 Digit Lot No. 141013 - 4 Digit Lot No. 1442.
Distribution pattern: 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.
Derived failure modes
-
Unknown
The intake port may be blocked which can cause the bag to fail to fill.