The Recall Desk
ModerateFDA (Devices)·Z-2012-2014·Announced 2014-07-16

Teleflex Medical Recalls Aquapak 640 SW Respiratory Gas Humidifier Adaptors

Teleflex Medical is recalling Aquapak 640 SW respiratory gas humidifier adaptors because creased packaging seals may affect integrity.

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, and the hazard involves potential packaging integrity issues without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Teleflex Medical is recalling Aquapak 640 SW, 650 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 affected product codes are 006-40, and the specific lot numbers are 041126, 042126, 043126, 044126, 053126, 054126, 055126, 056126, 057126, 058126, 068126, 069126, 070126, 075126, 077126, 078126, 079126, 086126, 087126, 088126, 089126, 090126, 097126, 111126, 120126, 121126, 122126, 123126, 128126, 155126, and 156126.

Healthcare facilities and distributors should check their inventory for the affected lot numbers and stop using the product if the packaging seals are creased. Users should contact Teleflex Medical for further instructions regarding the return or replacement of the affected units.

The recalled product

Product
Aquapak 640 SW, 650 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: 006-40
  • Lot numbers: 041126
  • 042126
  • 043126
  • 044126
  • 053126
  • 054126
  • 055126
  • 056126
  • 057126
  • 058126
  • 068126
  • 069126
  • 070126
  • 075126
  • 077126
  • 078126
  • 079126
  • 086126
  • 087126

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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