device · product 1 of 2
(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.
- Recall number
- Z-1126-2022
- Initiated
- April 11, 2022
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- TELEFLEX MEDICAL INC
- Quantity
- 59,581 eaches
App-derived interpretation
Reports received of torn corrugated breathing tubes.
Official device-enrichment evidence · Sourced
Device Design
Inspect official wording and provenance
Reason for recall
Reports received of torn corrugated breathing tubes.
Code information
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; KMZ21C0141 (01)04026704388721(17)260228(10)KMZ21C0141; KMZ21C0948 (01)04026704388721(17)260228(10)KMZ21C0948; KMZ21F0361 (01)04026704388721(17)260528(10)KMZ21F0361; and KMZ21F0627 (01)04026704388721(17)260528(10)KMZ21F0627.
Distribution pattern
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.