The Recall Desk
ModerateFDA (Devices)·Z-2010-2014·Announced 2014-07-16

Teleflex Medical Recalls Respiratory Gas Humidifier Adaptors Due to Packaging Seal Issues

Teleflex Medical is recalling Aqua 540 SW and 540 w/040 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 precautionary recall.

Plain-English summary

Teleflex Medical is recalling the Aqua 540 SW and 540 w/040 Adaptors, which are respiratory gas humidifier adaptors. The recall was initiated because the seals on the adaptor packaging may be creased, a condition that may potentially affect the integrity of the packaging.

The recall involves 7,758,650 units. These products 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 affected product code is 005-40, and the recall includes specific lot numbers ranging from 001125 to 032125.

The FDA has classified this as a Class II recall. Consumers and healthcare facilities should contact Teleflex Medical for instructions on how to return or replace the affected units.

The recalled product

Product
Aqua 540 SW, 540 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: 005-40
  • Lot numbers: 001125
  • 002125
  • 003125
  • 004125
  • 005125
  • 006125
  • 007125
  • 008125
  • 009125
  • 010125
  • 011125
  • 012125
  • 013125
  • 014125
  • 015125
  • 016125
  • 017125
  • 019125
  • 020125

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 →

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Same hazard · packaging integrity

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