The Recall Desk
HighFDA (Devices)·Z-1126-2022·Announced 2022-06-01

Gibeck Humid-Vent Breathing Filters Recalled for Torn Corrugated Tubes

Teleflex Medical is recalling Gibeck brand respiratory filters due to reports of torn corrugated breathing tubes. No injuries have been reported.

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: This is an FDA Class II recall of a safety-critical respiratory device with documented reports of the defect. No illnesses or injuries have been reported. The product presents a risk of harm by potentially compromising proper breathing assistance. Per the severity rubric, this qualifies as High (score 3) under the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Teleflex Medical Inc. is recalling five models of Gibeck Humid-Vent and Humid-Vent Filter Compact respiratory devices (59,581 units total) due to reports of torn corrugated breathing tubes. The affected products include sterile and non-sterile versions of the Gibeck Humid-Vent 2S Flex DC, the Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, and the Gibeck Humid-Vent Filter Compact S with Flex Tube.

The torn tubes can compromise the proper function of the breathing filter. These devices are designed to be used with ventilation equipment to humidify and filter air in patient care settings.

The recalled products have been distributed worldwide, including in multiple U.S. states and countries including Austria, Australia, Belgium, Canada, Chile, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Korea, Malaysia, Netherlands, Panama, Poland, Slovakia, Spain, and Switzerland.

Users and healthcare facilities should stop using the affected units and contact Teleflex Medical for instructions on replacement or return. Patients currently using these devices should consult with their healthcare provider.

The recalled product

Product
(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Prod
Manufacturer
TELEFLEX MEDICAL INC
Category
Medical Device — Respiratory / Breathing Filters
Hazard
  • breathing-tube-damage
  • respiratory-device-defect

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)

  • KMH21C0162 (01)04026704347919(17)260228(10)KMH21C0162
  • KMH21C0262 (01)04026704347919(17)260228(10)KMH21C0262
  • KMH21C0265 (01)04026704347919(17)260228(10)KMH21C0265
  • KMH21E0077 (01)04026704347919(17)260428(10)KMH21E0077
  • KMH21F0231 (01)04026704347919(17)260528(10)KMH21F0231
  • KMH21F0276 (01)04026704347919(17)260528(10)KMH21F0276
  • KMH21G0428 (01)04026704347919(17)260628(10)KMH21G0428
  • KMH21H0142 (01)04026704347919(17)260728(10)KMH21H0142
  • KMH21L0020 (01)04026704347919(17)261028(10)KMH21L0020
  • KMZ21G0742 (01)04026704347926(17)260628(10)KMZ21G0742
  • KMZ21G0989 (01)04026704347926(17)260628(10)KMZ21G0989
  • KMZ21G1049 (01)04026704347926(17)260628(10)KMZ21G1049
  • KMZ21K0159 (01)04026704347926(17)260928(10)KMZ21K0159
  • KMZ21K0160 (01)04026704347926(17)260928(10)KMZ21K0160
  • KMZ21K0275 (01)04026704347926(17)260928(10)KMZ21K0275
  • KMZ21K0451 (01)04026704347926(17)260928(10)KMZ21K0451
  • KMZ21L0103 (01)04026704347926(17)261028(10)KMZ21L0103
  • KMZ21L0602 (01)04026704347926(17)261028(10)KMZ21L0602
  • KMZ21C0125 (01)04026704347926(17)260228(10)KMZ21C0125
  • KMZ21C0235 (01)04026704347926(17)260228(10)KMZ21C0235

Distribution

Distributed nationwide across the United States.

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