The Recall Desk
LowFDA (Devices)·Z-2006-2014·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

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a packaging integrity issue (creased seals) without reporting any illnesses, injuries, or deaths. Per the rubric, packaging-only problems and theoretical hazards without reported harm are rated Low.

Plain-English summary

Teleflex Medical is recalling the Aquapak 340 SW, 340 mL w/040 Adaptor, a respiratory gas humidifier adaptor. The recall is due to a potential defect where the seals of the adaptor packaging may be creased, which could potentially affect packaging integrity.

The affected units were distributed nationwide in the United States as well as in Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, the Philippines, Singapore, Thailand, and Zambia. The total quantity involved in this recall is 7,758,650 units.

Healthcare facilities and distributors should check their inventory for the specific product code and lot numbers listed in the official recall notice. Users should stop using the affected adaptors and contact Teleflex Medical for instructions on return or replacement.

The recalled product

Product
Aquapak 340 SW, 340, mL w/040 Adaptor, 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: 003-40
  • Lot numbers: 088137
  • 093127
  • 095127
  • 096127
  • 098127
  • 099127
  • 101127
  • 103127
  • 105127
  • 107127
  • 111127
  • 112127
  • 113127
  • 114127
  • 115127
  • 116127
  • 117127
  • 118127
  • 119127

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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