The Recall Desk
ModerateFDA (Devices)·Z-2003-2014·Announced 2014-07-16

Teleflex Medical Recalls Aquapak 340 SW Respiratory Gas Humidifier Adaptors

Teleflex Medical is recalling Aquapak 340 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity. The recall covers units distributed in the US and 12 other countries.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to potential packaging integrity issues (creased seals) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Teleflex Medical is recalling Aquapak 340 SW, 340 mL w/040 Adaptor, International, respiratory gas humidifier adaptors. The recall involves 7,758,650 units. The product is distributed in the United States (nationwide) and in Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, Philippines, Singapore, Thailand, and Zambia.

The recall is due to a potential defect where the seals of the packaging may be creased. This condition may potentially affect the integrity of the packaging. The agency has classified this as a Class II recall.

Consumers and healthcare facilities should check their inventory for the specific product code 400340 and the listed lot numbers. If the product is found, it should be removed from use and returned to Teleflex Medical or the distributor.

The recalled product

Product
Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor .
Manufacturer
Teleflex Medical
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
7,758,650

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: 400340
  • Lot numbers: 082127
  • 085127
  • 088127
  • 092127
  • 094127
  • 097127
  • 100127
  • 102127
  • 104127
  • 106127
  • 108127
  • 137127
  • 141127
  • 145127
  • 148127
  • 154127
  • 156127
  • 159127
  • 161127

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by Teleflex Medical 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 15 products in this recall →

Related recalls

Same manufacturer · Teleflex Medical

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Same hazard · packaging integrity

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