(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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- TELEFLEX MEDICAL INC
- Reason for Recall:
- Reports received of torn corrugated breathing tubes.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
(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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1126-2022
Related Recalls
Reports received of torn corrugated breathing tubes.
The firm received reports indicating PTD tip separation during use.
The firm received reports indicating PTD tip separation during use.