The Recall Desk
LowFDA (Devices)·Z-2009-2014·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.

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 hazard is limited to potential packaging integrity issues with no reported injuries or illnesses, fitting the criteria for a low-severity packaging-only problem.

Plain-English summary

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

The recall was initiated because the seals of the adaptor packaging may be creased, which may potentially affect packaging integrity. The source text does not report any illnesses, injuries, or deaths associated with this recall.

Healthcare facilities and consumers should stop using the affected adaptors and contact Teleflex Medical for instructions on return or replacement. The affected product code is 003-40J, and the recall includes specific lot numbers listed in the official FDA notice.

The recalled product

Product
Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, 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: 003-40J
  • Lot numbers: 177127
  • 181127
  • 184127
  • 225127
  • 227127
  • 229127
  • 231127
  • 254127
  • 287127
  • 291127
  • 293127
  • 363127
  • 364127
  • 365127
  • 366127
  • 367127
  • 385127
  • 387127
  • 389127

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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