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FDAFDA · Food and drugs·Recall number Z-1126-2022

(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, Product #19062, non-sterile; and (5) Gibeck Humid-Vent Filter Compact S with Flex Tube, Product #19812, non-sterile.

Published June 1, 2022 · Recall initiated: April 11, 2022

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Reports received of torn corrugated breathing tubes.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
TELEFLEX MEDICAL INC
Distributor
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of Austria, Australia, Belgium, Canada, Chile, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Korea, Malaysia, Netherlands, Panama, Poland, Slovakia, Spain, and Switzerland.
Lot
Batch and UDI numbers: (1) Product 17731: KMH21C0130 (01)04026704347919(17)260228(10)KMH21C0130; 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; and KMH22A0068 (01)04026704347919(17)261228(10)KMH22A0068. (2) Product 17732: KMZ21G0733 (01)04026704347926(17)260628(10)KMZ21G0733; 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; KMZ21C0300 (01)04026704347926(17)260228(10)KMZ21C0300; KMZ21C0347 (01)04026704347926(17)260228(10)KMZ21C0347; KMZ21C0351 (01)04026704347926(17)260228(10)KMZ21C0351; KMZ21C0475 (01)04026704347926(17)260228(10)KMZ21C0475; KMZ21C0609 (01)04026704347926(17)260228(10)KMZ21C0609; KMZ21C0851 (01)04026704347926(17)260228(10)KMZ21C0851; KMZ21C0863 (01)04026704347926(17)260228(10)KMZ21C0863; KMZ21C1154 (01)04026704347926(17)260228(10)KMZ21C1154; KMZ21C1342 (01)04026704347926(17)260228(10)KMZ21C1342; KMZ21D0016 (01)04026704347926(17)260328(10)KMZ21D0016; KMZ21D0200 (01)04026704347926(17)260328(10)KMZ21D0200; KMZ21D0311 (01)04026704347926(17)260328(10)KMZ21D0311; KMZ21D0357 (01)04026704347926(17)260328(10)KMZ21D0357; KMZ21D0404 (01)04026704347926(17)260328(10)KMZ21D0404; KMZ21D0481 (01)04026704347926(17)260328(10)KMZ21D0481; KMZ21D0510 (01)04026704347926(17)260328(10)KMZ21D0510; KMZ21E0096 (01)04026704347926(17)260428(10)KMZ21E0096; KMZ21F0475 (01)04026704347926(17)260528(10)KMZ21F0475; KMZ21F0483 (01)04026704347926(17)260528(10)KMZ21F0483; KMZ21F0484 (01)04026704347926(17)260528(10)KMZ21F0484; and KMZ21F0873 (01)04026704347926(17)260528(10)KMZ21F0873. (3) Product 19061: KMH21F0418 (01)04026704388387(17)260528(10)KMH21F0418; KMH21G0357 (01)04026704388387(17)260628(10)KMH21G0357; KMH21H0060 (01)04026704388387(17)260728(10)KMH21H0060; KMH21H0062 (01)04026704388387(17)260728(10)KMH21H0062; KMH21H0252 (01)04026704388387(17)260728(10)KMH21H0252; KMH21J0021 (01)04026704388387(17)260828(10)KMH21J0021; KMH21J0260 (01)04026704388387(17)260828(10)KMH21J0260; KMH21K0159 (01)04026704388387(17)260928(10)KMH21K0159; KMH21K0375 (01)04026704388387(17)260928(10)KMH21K0375; KMH21L0139 (01)04026704388387(17)261028(10)KMH21L0139; KMH21C0188 (01)04026704388387(17)260228(10)KMH21C0188; KMH21C0191 (01)04026704388387(17)260228(10)KMH21C0191; KMH21C0194 (01)04026704388387(17)260228(10)KMH21C0194; KMH21C0280 (01)04026704388387(17)260228(10)KMH21C0280; KMH21C0388 (01)04026704388387(17)260228(10)KMH21C0388; KMH21D0094 (01)04026704388387(17)260328(10)KMH21D0094; KMH21D0289 (01)04026704388387(17)260328(10)KMH21D0289; KMH21D0290 (01)04026704388387(17)260328(10)KMH21D0290; KMH21E0240 (01)04026704388387(17)260428(10)KMH21E0240; and KMH21F0155 (01)04026704388387(17)260528(10)KMH21F0155. (4) Product 19062: KMZ21C0425 (01)04026704388394(17)260228(10)KMZ21C0425; KMZ21C0923 (01)04026704388394(17)260228(10)KMZ21C0923; and KMZ21F0379 (01)04026704388394(17)260528(10)KMZ21F0379. (5) Product 19812: KMZ21G0681 (01)04026704388721(17)260628(10)KMZ21G0681; KMZ21G0710 (01)04026704388721(17)260628(10)KMZ21G0710; KMZ21K0459 (01)04026704388721(17)260928(10)KMZ21K0459; KMZ21C
Risk classification
Class II
Area (FDA)
device
Country
United States

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