The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1809-2015·Announced 2015-07-01

Teleflex Recalls Lifesaver Manual Resuscitators Due to Potential Intake Port Blockage

Teleflex Medical is recalling 9,333 units of Lifesaver Single Patient Use Manual Resuscitators because the intake port may be blocked, causing the bag to fail to fill.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The intake port may be blocked which can cause the bag to fail to fill."

Plain-English summary

Teleflex Medical is recalling 9,333 units of the Lifesaver Single Patient Use Manual Resuscitator. This disposable medical device is intended for use on patients requiring temporary augmentation of ventilation with or without supplemental oxygen delivery during episodes of acute ventilatory failure or insufficiency.

The recall was initiated because the intake port of the device may be blocked. This defect can cause the resuscitator bag to fail to fill, potentially compromising the device's ability to provide ventilation support.

The affected units were distributed worldwide, including nationwide in the United States and in specific countries such as Australia, the Bahamas, Canada, Guatemala, and Mexico. Users should check their inventory for the specific product codes and lot numbers listed in the official recall notice and stop using any affected units immediately.

The recalled product

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…
Manufacturer
Teleflex Medical
Category
Medical Device — Respiratory / Ventilation
Hazard
Affected units
9,333

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 32 states specifically:

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