TELEFLEX MEDICAL INC: (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

Recalling firm

TELEFLEX MEDICAL INC

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

Status

Open, Classified

Initiated

2022-04-11

Posted

not on file

Terminated

not on file

Reason

Reports received of torn corrugated breathing tubes.

Root cause

Device Design

Action

The recalling firm issued letters dated April 2022 on 4/11/2022 via FedEx 2-day mail. The letter described the issue, the immediate actions required including the hazards involved, and provided specific actions to be taken and instructions to be followed by the medical facilities or the distributors. For the medical facilities, they are to cease use and distribution of the impacted product and immediately quarantine it. If the product is in inventory, indicate the information on the Acknowledgment Form and FAX it to Customer Service or email it to the firm. A customer service representative will contact the medical facility with a Return Goods Authorization number and provide instructions for return of the product to Teleflex. The Acknowledgment Form should also be returned if no product is in inventory. For distributors, they are to provide the recall letter to all customers who have received the product. Each customer is required to complete and return the Acknowledgement Form. The distributor is also supposed to check their inventory, cease distribution and quarantine the affected product. The Acknowledgment Form is to be completed and returned for product in their inventory as well as if they have no inventory. If the distributor has distributed product outside of the country, they are to notify Teleflex Customer Service. Additionally, the recall letter says that this notice should be passed onto all persons who need to be aware within their organization or to any organizations where the potentially affected devices have been transferred. This would include users, clinicians, risk managers, supply chain/distribution centers, etc. in the circulation of the notice.

Quantity

59,581 eaches

Distribution

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, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

BYD

Firm FEI

3005747797

Firm city

Morrisville

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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