The Recall Desk
HighFDA (Devices)·Z-0504-2015·Announced 2014-12-10

Teleflex Medical Recalls Aquapak Nebulizer Adaptors Due to Sterility Concerns

Teleflex Medical is recalling Aquapak Nebulizer Adaptors because packaging seals may be open or weak, potentially compromising the sterility of the devices.

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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria for potential loss of sterility.

Plain-English summary

Teleflex Medical is recalling specific lots of Aquapak Adaptors and Aqaupak Nebulizer Adaptors. The recall involves 3,193,548 units distributed worldwide, including the United States and numerous international markets. These medical devices are used in anesthesiology.

The recall was initiated due to a possibility that the nebulizer adaptor packaging may have open or weak seals. This defect may affect the sterility of the adaptor, which is a critical requirement for devices used in anesthesiology.

Healthcare facilities and distributors should stop using the affected products and contact Teleflex Medical for instructions on return or replacement. Consumers should not use these products if they are in their possession.

The recalled product

Product
Aquapak Adaptor, 028 NEB, INTL, Product No. 403128; Aquapak Adaptor, 033 NEB, INTL, Product No. 403133; Aqaupak Nebulizer Adaptor 028, Sterile, Shelfpak, Product No. 031-28 & 031-28F, Aqaupak Nebulizer Adaptor 033, Sterile, Shelfpak, Product No. 031-33; Aqaupak Nebulizer Adaptor
Manufacturer
Teleflex Medical
Category
Medical Device — Anesthesiology Equipment
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. 043128
  • Lot # 02E1200719
  • 02E1200720
  • 02E1201281
  • 02F1200964
  • 02K1201946
  • 02E1201808
  • 02E1203097
  • 02G1300256
  • 02G1301048
  • & 02M1201691
  • Product No. 403133
  • Lot # 02E1201282
  • 02K1201948
  • 02F1200965
  • 02L1201194
  • 02M1200230
  • & 02F1302063
  • Product No. 031-28
  • Lot # 02D1202234

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 · loss of sterility

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