The Recall Desk
LowFDA (Devices)·Z-2004-2014·Announced 2014-07-16

Teleflex Medical Recalls Aquapak Respiratory Gas Humidifier Adaptors for Packaging Defects

Teleflex Medical is recalling Aquapak 640 SW and 650 mL 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 source text explicitly states that the hazard is a potential packaging integrity issue (creased seals) with no reported illnesses, injuries, or deaths. This aligns with the 'Low' severity criteria for packaging-only problems.

Plain-English summary

Teleflex Medical is voluntarily recalling approximately 7.76 million units of Aquapak 640 SW and 650 mL respiratory gas humidifier adaptors. The recall was initiated because the seals on the product packaging may be creased, which could potentially affect the integrity of the packaging.

The affected products were distributed worldwide, including in the United States and in Belgium, Canada, China, Germany, Great Britain, France, India, Malaysia, Mexico, the Philippines, Singapore, Thailand, and Zambia. The recall covers specific lot numbers ranging from 021126 to 151126.

Healthcare facilities and distributors should stop using the affected adaptors and contact Teleflex Medical for instructions on how to return or dispose of the products. Consumers who have purchased these items should also contact the manufacturer for guidance.

The recalled product

Product
Aquapak 640 SW, 650, 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: 400640
  • Lot numbers: 021126
  • 022126
  • 030126
  • 031126
  • 032126
  • 033126
  • 034126
  • 037126
  • 038126
  • 039126
  • 040126
  • 047126
  • 048126
  • 049126
  • 050126
  • 051126
  • 052126
  • 059126
  • 060126

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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