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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Teleflex Medical
Reason for Recall:
The intake port may be blocked which can cause the bag to fail to fill.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1809-2015

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