Z-1127-2022Class II

(1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product...

Name: Z-1127-2022 (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product...
Creator: Teleflex Medical Inc
Published: 2022-04-11
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2022-04-11 / Open, Classified / root cause: design

FDA source

TELEFLEX MEDICAL INC began a recall of (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with... on 2022-04-11. FDA classified it as Class II and gives the reason as "Reports received of torn corrugated breathing tubes". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1127-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-11
Posted: 2022-05-24
Recalling firm: Teleflex Medical
Product: (1) Teleflex Flex tube, Product #20011, sterile; (2) Teleflex Smooth-Flo Flex with Double Swivel, Product #22511, sterile; (3) Teleflex Smooth-Flo Flex with Double Swivel, Product #22512, non-sterile; (4) Teleflex Smooth-Flo Flex, Product #22552, non-sterile.
Product code: BZO Set, Tubing And Support, Ventilator (W Harness)
Reason for recall: Reports received of torn corrugated breathing tubes.
Root cause tag: design
FDA 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 in commerce: 290,809 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.
Product codes and lots: Batch and UDI numbers: (1) Product 20011: KMH21F0393 (01)04026704388769(17)260528(10)KMH21F0393; KMH21F0394 (01)04026704388769(17)260528(10)KMH21F0394; KMH21F0395 (01)04026704388769(17)260528(10)KMH21F0395; KMH21F0412 (01)04026704388769(17)260528(10)KMH21F0412; KMH21H0094 (01)04026704388769(17)260728(10)KMH21H0094; KMH21H0095 (01)04026704388769(17)260728(10)KMH21H0095; KMH21H0096 (01)04026704388769(17)260728(10)KMH21H0096; KMH21H0110 (01)04026704388769(17)260728(10)KMH21H0110; KMH21H0112 (01)04026704388769(17)260728(10)KMH21H0112; KMH21J0109 (01)04026704388769(17)260828(10)KMH21J0109; KMH21J0110 (01)04026704388769(17)260828(10)KMH21J0110; KMH21J0118 (01)04026704388769(17)260828(10)KMH21J0118; KMH21J0121 (01)04026704388769(17)260828(10)KMH21J0121; KMH21J0124 (01)04026704388769(17)260828(10)KMH21J0124; KMH21K0302 (01)04026704388769(17)260928(10)KMH21K0302; KMH21K0303 (01)04026704388769(17)260928(10)KMH21K0303; KMH21K0306 (01)04026704388769(17)260928(10)KMH21K0306; KMH21K0307 (01)04026704388769(17)260928(10)KMH21K0307; KMH21K0308 (01)04026704388769(17)260928(10)KMH21K0308; KMH21K0320 (01)04026704388769(17)260928(10)KMH21K0320; KMH21K0341 (01)04026704388769(17)260928(10)KMH21K0341; KMH21K0345 (01)04026704388769(17)260928(10)KMH21K0345; KMH21L0156 (01)04026704388769(17)261028(10)KMH21L0156; KMH21B0479 (01)04026704388769(17)260128(10)KMH21B0479; KMH21B0480 (01)04026704388769(17)260128(10)KMH21B0480; KMH21B0482 (01)04026704388769(17)260128(10)KMH21B0482; KMH21B0483 (01)04026704388769(17)260128(10)KMH21B0483; KMH21C0229 (01)04026704388769(17)260228(10)KMH21C0229; KMH21C0230 (01)04026704388769(17)260228(10)KMH21C0230; KMH21C0231 (01)04026704388769(17)260228(10)KMH21C0231; KMH21C0232 (01)04026704388769(17)260228(10)KMH21C0232; KMH21C0241 (01)04026704388769(17)260228(10)KMH21C0241; KMH21C0242 (01)04026704388769(17)260228(10)KMH21C0242; KMH21C0245 (01)04026704388769(17)260228(10)KMH21C0245; KMH21C0246 (01)04026704388769(17)260228(10)KMH21C0246; KMH21C0252 (01)04026704388769(17)260228(10)KMH21C0252; KMH21C0366 (01)04026704388769(17)260228(10)KMH21C0366; KMH21C0367 (01)04026704388769(17)260228(10)KMH21C0367; KMH21C0368 (01)04026704388769(17)260228(10)KMH21C0368; KMH21C0377 (01)04026704388769(17)260228(10)KMH21C0377; KMH21C0378 (01)04026704388769(17)260228(10)KMH21C0378; KMH21D0204 (01)04026704388769(17)260328(10)KMH21D0204; KMH21D0205 (01)04026704388769(17)260328(10)KMH21D0205; KMH21D0206 (01)04026704388769(17)260328(10)KMH21D0206; KMH21E0002 (01)04026704388769(17)260428(10)KMH21E0002; KMH21E0003 (01)04026704388769(17)260428(10)KMH21E0003; KMH21E0004 (01)04026704388769(17)260428(10)KMH21E0004; KMH21F0196 (01)04026704388769(17)260528(10)KMH21F0196; KMH21F0197 (01)04026704388769(17)260528(10)KMH21F0197; KMH21F0198 (01)04026704388769(17)260528(10)KMH21F0198; KMH21F0199 (01)04026704388769(17)260528(10)KMH21F0199; and KMH21F0210 (01)04026704388769(17)260528(10)KMH21F0210. (2) Product 22511 KMH21F0419 (01)04026704388783(17)260528(10)KMH21F0419; KMH21F0433 (01)04026704388783(17)260528(10)KMH21F0433; KMH21G0362 (01)04026704388783(17)260628(10)KMH21G0362; KMH21G0363 (01)04026704388783(17)260628(10)KMH21G0363; KMH21G0439 (01)04026704388783(17)260628(10)KMH21G0439; KMH21H0061 (01)04026704388783(17)260728(10)KMH21H0061; KMH21H0171 (01)04026704388783(17)260728(10)KMH21H0171; KMH21H0199 (01)04026704388783(17)260728(10)KMH21H0199; KMH21H0222 (01)04026704388783(17)260728(10)KMH21H0222; KMH21H0248 (01)04026704388783(17)260728(10)KMH21H0248; KMH21J0209 (01)04026704388783(17)260828(10)KMH21J0209; KMH21J0220 (01)04026704388783(17)260828(10)KMH21J0220; KMH21K0168 (01)04026704388783(17)260928(10)KMH21K0168; KMH21K0376 (01)04026704388783(17)260928(10)KMH21K0376; KMH21K0385 (01)04026704388783(17)260928(10)KMH21K0385; KMH21B0490 (01)04026704388783(17)260128(10)KMH21B0490; KMH21C0159 (01)04026704388783(17)260228(10)KMH21C0159; KMH21C0160 (01)04026704388783(17)260228(10)KMH21C0160; KMH21D0172 (01)04026704388783(17)260328(10)KMH21D0172; KMH21D0316 (01)04026704388783(17)260328(10)KMH21D0316; KMH21D0360 (01)04026704388783(17)260328(10)KMH21D0360; KMH21E0024 (01)04026704388783(17)260428(10)KMH21E0024; KMH21E0223 (01)04026704388783(17)260428(10)KMH21E0223; KMH21F0148 (01)04026704388783(17)260528(10)KMH21F0148; KMH21F0232 (01)04026704388783(17)260528(10)KMH21F0232; and KMH21F0272 (01)04026704388783(17)260528(10)KMH21F0272. (3) Product 22512: KMZ21F0898 (01)04026704388790(17)260528(10)KMZ21F0898; KMZ21G0757 (01)04026704388790(17)260628(10)KMZ21G0757; KMZ21G0865 (01)04026704388790(17)260628(10)KMZ21G0865; KMZ21H0006 (01)04026704388790(17)260728(10)KMZ21H0006; KMZ21H0106 (01)04026704388790(17)260728(10)KMZ21H0106; KMZ21J0245 (01)04026704388790(17)260828(10)KMZ21J0245; KMZ21J0302 (01)04026704388790(17)260828(10)KMZ21J0302; KMZ21J0504 (01)04026704388790(17)260828(10)KMZ21J0504; KMZ21J0505 (01)04026704388790(17)260828(10)KMZ21J0505; KMZ21J0538 (01)04026704388790(17)260828(10)KMZ21J0538; KMZ21L0084 (01)04026704388790(17)261028(10)KMZ21L0084; KMZ21L0407 (01)04026704388790(17)261028(10)KMZ21L0407; KMZ21L0660 (01)04026704388790(17)261028(10)KMZ21L0660; KMZ21C0007 (01)04026704388790(17)260228(10)KMZ21C0007; KMZ21C0166 (01)04026704388790(17)260228(10)KMZ21C0166; KMZ21C0372 (01)04026704388790(17)260228(10)KMZ21C0372; KMZ21C0422 (01)04026704388790(17)260228(10)KMZ21C0422; KMZ21C0722 (01)04026704388790(17)260228(10)KMZ21C0722; KMZ21C0744 (01)04026704388790(17)260228(10)KMZ21C0744; KMZ21C0924 (01)04026704388790(17)260228(10)KMZ21C0924; KMZ21C1306 (01)04026704388790(17)260228(10)KMZ21C1306; KMZ21D0858 (01)04026704388790(17)260328(10)KMZ21D0858; KMZ21D0926 (01)04026704388790(17)260328(10)KMZ21D0926; KMZ21D1057 (01)04026704388790(17)260328(10)KMZ21D1057; KMZ21D1116 (01)04026704388790(17)260328(10)KMZ21D1116; KMZ21E0135 (01)04026704388790(17)260428(10)KMZ21E0135; KMZ21E0203 (01)04026704388790(17)260428(10)KMZ21E0203; KMZ21E0360 (01)04026704388790(17)260428(10)KMZ21E0360; KMZ21F0387 (01)04026704388790(17)260528(10)KMZ21F0387; KMZ21F0554 (01)04026704388790(17)260528(10)KMZ21F0554; KMZ21F0595 (01)04026704388790(17)260528(10)KMZ21F0595; and KMZ21F0702 (01)04026704388790(17)260528(10)KMZ21F0702. (4) Product 22552 KMZ21G0680 (01)04026704388851(17)260628(10)KMZ21G0680; KMZ21G0689 (01)04026704388851(17)260628(10)KMZ21G0689; KMZ21G0711 (01)04026704388851(17)260628(10)KMZ21G0711; KMZ21G0801 (01)04026704388851(17)260628(10)KMZ21G0801; KMZ21H0181 (01)04026704388851(17)260728(10)KMZ21H0181; KMZ21H0182 (01)04026704388851(17)260728(10)KMZ21H0182; KMZ21J0246 (01)04026704388851(17)260828(10)KMZ21J0246; KMZ21J0401 (01)04026704388851(17)260828(10)KMZ21J0401; KMZ21J0584 (01)04026704388851(17)260828(10)KMZ21J0584; KMZ21K0364 (01)04026704388851(17)260928(10)KMZ21K0364; KMZ21K0365 (01)04026704388851(17)260928(10)KMZ21K0365; KMZ21K0608 (01)04026704388851(17)260928(10)KMZ21K0608; KMZ21B1212 (01)04026704388851(17)260128(10)KMZ21B1212; KMZ21B1213 (01)04026704388851(17)260128(10)KMZ21B1213; KMZ21B1241 (01)04026704388851(17)260128(10)KMZ21B1241; KMZ21C0130 (01)04026704388851(17)260228(10)KMZ21C0130; KMZ21C1266 (01)04026704388851(17)260228(10)KMZ21C1266; KMZ21D0957 (01)04026704388851(17)260328(10)KMZ21D0957; KMZ21F0181 (01)04026704388851(17)260528(10)KMZ21F0181; KMZ21F0182 (01)04026704388851(17)260528(10)KMZ21F0182; and KMZ21F0518 (01)04026704388851(17)260528(10)KMZ21F0518.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1127-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1126-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-01	2022-05-24
Z-1127-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-01	2022-05-24

Product code BZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)