The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0181-2013·Announced 2012-11-07

Ventlab AirFlow Resuscitator Recalled for Possible Volume Leakage

Ventlab Corporation is recalling specific lots of AirFlow Small Adult Resuscitators due to possible volume leakage through the inlet valve during compressions.

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 AirFlow, Small Adult Resuscitator, AF5000 Series, Single use. The recall covers specific product codes and lot numbers, including AF5140MBPWTD5, AF5140MB-T, AFD5140MB-T, AF5140MBS-I, AF5140MB-ST, AF5140MBS, and AF5140MBS-R.

The recall was initiated because of a possible volume leakage through the inlet valve during compressions of the resuscitator bag. These devices are intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

The affected units were distributed nationwide, including in Illinois, Ohio, New York, and Tennessee. The source text does not specify further actions for consumers or healthcare providers beyond the recall notice.

The recalled product

Product
AirFlow, Small Adult Resuscitator, AF5000 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 of…
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 (11)

  • Product Code: AF5140MBPWTD5
  • Lot #101806 and 102163
  • AF5140MB-T
  • Lot #102075 and AFD5140MB-T
  • Lot #101928 &102211. Recall was amended to include the following: AF5140MBS-I
  • Lot #101898
  • AF5140MB-ST
  • Lot #101896
  • AF5140MBS
  • Lot #101900 and AF5140MBS-R
  • Lot #101899.

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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