HUDSON RCI recallZ-1127-2022 · Teleflex Medical Inc · initiated Apr 11, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Teleflex Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reports received of torn corrugated breathing tubes.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1127-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 11, 2022
- Recalling firm
- Teleflex Medical Inc
- Quantity
- 290,809 eaches
- Product code
- BZO
- 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 description
(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.
Code information (models, lots, serial numbers)
Show the full code information (7k characters)
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.
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- HUDSON RCI IPN043837Teleflex Incorporated · SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)1 recall18 reports
- HUDSON RCI IPN044019Teleflex Incorporated · SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)1 recall0 reports
- HUDSON RCI IPN044020Teleflex Incorporated · SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)1 recall0 reports
- HUDSON RCI IPN044039Teleflex Incorporated · SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 90014).
- Z-1126-2022 · Open, Classified(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/S…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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