The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0174-2013·Announced 2012-11-07

Ventlab Infant Resuscitator Recalled for Possible Volume Leakage

Ventlab is recalling 14,602 Safe Spot Infant Resuscitators due to a defect that may cause air to leak through the inlet valve during use.

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: "Possible volume leakage through the inlet valve during compressions of the resuscitator bag."

Plain-English summary

Ventlab Corporation is recalling 14,602 units of the Breath Tech Safe Spot Infant Resuscitator, BT2000 Series. These single-use medical devices are intended to provide respiratory support for infants experiencing reversible apnea, such as during cardiopulmonary arrest. The recall covers specific product codes and lot numbers, including BT2200FK, BT2216, and BT2420FK.

The recall was initiated because of a possible volume leakage through the inlet valve during compressions of the resuscitator bag. This defect could compromise the device's ability to deliver the intended respiratory support. The affected units were distributed nationwide, with specific mentions of Illinois, Ohio, New York, and Tennessee.

Healthcare facilities and consumers who possess these specific lot numbers should stop using the devices immediately. Ventlab Corporation is the recalling firm responsible for managing the recall process.

The recalled product

Product
Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence…
Manufacturer
Ventlab Corporation
Category
Medical Device — Respiratory Support
Hazard
Affected units
14,602

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)

  • Code: Product List 071012
  • Product Codes: BT2200FK
  • Lot #100196
  • BT2216
  • Lot #100138
  • BT2216F
  • Lot #100139
  • BT2216K
  • Lot #100197
  • BT2220
  • Lot #100140
  • Lot #100141
  • BT2416
  • Lot #100142
  • BT2416F
  • Lot #100143
  • BT2416K
  • Lot #100198
  • BT2420
  • Lot #100144

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 12 recalled by Ventlab Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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