The Recall Desk
HighFDA (Devices)·Z-0505-2015·Announced 2014-12-10

Teleflex Medical Recalls Aquapak Nebulizer Adaptors Due to Seal Integrity Concerns

Teleflex Medical is recalling Aquapak nebulizer adaptors because packaging seals may be open or weak, potentially affecting the sterility of the device.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (loss of sterility) for a medical device where injury has not yet been reported.

Plain-English summary

Teleflex Medical is recalling specific lots of Aquapak nebulizer adaptors used in anesthesiology. The recall involves approximately 3.2 million units distributed worldwide, including the United States and numerous international markets.

The recall was initiated because the nebulizer adaptor packaging may have open or weak seals. This defect may affect the sterility of the adaptor, which is a critical safety requirement for medical devices used in clinical settings.

Healthcare facilities and distributors should check their inventory for the specific product numbers and lot numbers listed in the official FDA recall notice. Affected units should be removed from service and returned to Teleflex Medical according to the company's instructions.

The recalled product

Product
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 76
Manufacturer
Teleflex Medical
Category
Medical Device — Anesthesiology
Hazard
Affected units
3,193,548

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 No. 403728
  • Lot #104120
  • 114120
  • 132120
  • 120120
  • 155120
  • 158120
  • 144120
  • 164120
  • 008130
  • 013130
  • 023130
  • 035130
  • 038130
  • 049130
  • 060130
  • 072130
  • 054130
  • 100130
  • 115130

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Teleflex Medical

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Same hazard · sterility compromise

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