Z-1011-2023Class II

Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal...

Name: Z-1011-2023 Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal...
Creator: Teleflex Llc
Published: 2022-12-08
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2022-12-08 / Open, Classified / root cause: manufacturing process

FDA source

TELEFLEX LLC began a recall of Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High... on 2022-12-08. FDA classified it as Class II and gives the reason as "Potential for pilot balloon non-inflation or cuff non-deflation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1011-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-08
Posted: 2023-01-23
Recalling firm: Teleflex Medical
Product: Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: Potential for pilot balloon non-inflation or cuff non-deflation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Teleflex issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/08/2022 by FedEx 2nd day mail. The notices explain the issues, risk, and requested the following: "Action list number 1 Medical facilities 1. We request that you immediately check your inventory for product within the scope of this FSCA. Users should cease use and distribution of affected product and immediately quarantine the affected product. 2. If you have impacted product, mark the applicable checkbox on the Acknowledgement Form (Appendix 1) and fax it to 1-855-419-8507, including Attn: Customer Service or using the email address [email protected]. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you do not have impacted product, mark the applicable checkbox on the Acknowledgement Form (Appendix 1) and return the form to Teleflex at the contact details provided. 4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product. Action list number 2 Distributors 1. Provide this field safety notice to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you. 2. We request that you immediately check your inventory for impacted product. Cease use and distribution of impacted product and immediately quarantine the affected product. You may then return all product in scope. 3. As a distributor, you are then required to confirm to Teleflex that you have completed the field activity outlined in actions 1 and 2 of this Action List Number 2. Upon completion of your actions, please forward the completed Acknowledgement Form to the e-mail address below. Important - Please ensure you only list batch numbers in scope of this Field Safety Notice
Quantity in commerce: 39,690 units
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, PA, SC, SD, TX, UT, VA, WA, WI, WV and PR. The countries of Albania, Armenia, Austria, Azerbaijan, Bahamas, Barbados, Belgium, Brazil, Bulgaria, Burkina Faso, Canada, Chile, China, Croatia, Cyprus, Czech, Denmark, El Salvador, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Great Britain, Greece, Hong Kong, Hungary, Iceland, Ireland, Italy Israel, Jordan, Kuwait, Lebanon, Liechtenstein, Malaysia, Mayotte, Mexico, Moldova, Morocco, Nepal, Netherlands, Norway, Panama, Philippines, Poland, Portugal, R¿union, Russia, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, South Africa, South Korea, Sweden, Switzerland, Taiwan Thailand, Turkey, Ukraine, United Arab Emirates.
Product codes and lots: a. Product Code, Batch Number (UDI): 504550, KME21D1964 ((01)4026704547579(17)260328(10)KME21D1964), 504560, KME21E1412 ((01)4026704547593(17)260428(10)KME21E1412), 504580, KME21D1784 ((01)4026704547630(17)260328(10)KME21D1784), 504580, KME21E1286 ((01)4026704547630(17)260428(10)KME21E1286), 504585, KME21E1295 ((01)4026704547647(17)260428(10)KME21E1295), 504590, KME21E1114 ((01)4026704547654(17)260428(10)KME21E1114); b. Product Code, Batch Number (UDI): 112082050, KME21F0727 ((01)14026704341389(17)260528(10)KME21F0727), 112082050, KME21F0321 ((01)14026704341389(17)260528(10)KME21F0321), 112082055, KME21E0864 ((01)14026704341396(17)260428(10)KME21E0864), 112082055, KME21F0946 ((01)14026704341396(17)260528(10)KME21F0946), 112082055, KME21E1230 ((01)14026704341396(17)260428(10)KME21E1230), 112082060, KME21E0660 ((01)14026704341402(17)260428(10)KME21E0660), 112082060, KME21E1391 ((01)14026704341402(17)260428(10)KME21E1391), 112082065, KME21E0607 ((01)14026704341419(17)260428(10)KME21E0607), 112082065, KME21E0685 ((01)14026704341419(17)260428(10)KME21E0685), 112082065, KME21F0384 ((01)14026704341419(17)260528(10)KME21F0384), 112082065, KME21F0516 ((01)14026704341419(17)260528(10)KME21F0516), 112082065, KME21F0694 ((01)14026704341419(17)260528(10)KME21F0694), 112082065, KME21F0834 ((01)14026704341419(17)260528(10)KME21F0834), 112082065, KME21F0930 ((01)14026704341419(17)260528(10)KME21F0930), 112082070, KME21D2935 ((01)14026704341426(17)260328(10)KME21D2935), 112082070, KME21E0002 ((01)14026704341426(17)260428(10)KME21E0002), 112082070, KME21E0363 ((01)14026704341426(17)260428(10)KME21E0363), 112082070, KME21E1390 ((01)14026704341426(17)260428(10)KME21E1390), 112082070, KME21D1580 ((01)14026704341426(17)260328(10)KME21D1580), 112082070, KME21D1652 ((01)14026704341426(17)260328(10)KME21D1652), 112082070, KME21D1706 ((01)14026704341426(17)260328(10)KME21D1706), 112082070, KME21D1878 ((01)14026704341426(17)260328(10)KME21D1878), 112082070, KME21D2020 ((01)14026704341426(17)260328(10)KME21D2020), 112082070, KME21D2929 ((01)14026704341426(17)260328(10)KME21D2929), 112082070, KME21E0001 ((01)14026704341426(17)260428(10)KME21E0001), 112082070, KME21F0102 ((01)14026704341426(17)260528(10)KME21F0102), 112082070, KME21F0140 ((01)14026704341426(17)260528(10)KME21F0140), 112082070, KME21F0239 ((01)14026704341426(17)260528(10)KME21F0239), 112082070, KME21F0434 ((01)14026704341426(17)260528(10)KME21F0434), 112082075, KME21E0288 ((01)14026704341433(17)260428(10)KME21E0288), 112082075, KME21E1150 ((01)14026704341433(17)260428(10)KME21E1150), 112082075, KME21E1178 ((01)14026704341433(17)260428(10)KME21E1178), 112082075, KME21E1186 ((01)14026704341433(17)260428(10)KME21E1186), 112082075, KME21F0557 ((01)14026704341433(17)260528(10)KME21F0557), 112082075, KME21D1705 ((01)14026704341433(17)260328(10)KME21D1705), 112082075, KME21D1780 ((01)14026704341433(17)260328(10)KME21D1780), 112082075, KME21D1923 ((01)14026704341433(17)260328(10)KME21D1923), 112082075, KME21D1956 ((01)14026704341433(17)260328(10)KME21D1956), 112082075, KME21D2014 ((01)14026704341433(17)260328(10)KME21D2014), 112082075, KME21D2018 ((01)14026704341433(17)260328(10)KME21D2018), 112082075, KME21D2262 ((01)14026704341433(17)260328(10)KME21D2262), 112082075, KME21E0021 ((01)14026704341433(17)260428(10)KME21E0021), 112082075, KME21E0498 ((01)14026704341433(17)260428(10)KME21E0498), 112082075, KME21E0469 ((01)14026704341433(17)260428(10)KME21E0469), 112082075, KME21F0351 ((01)14026704341433(17)260528(10)KME21F0351), 112082075, KME21E1264 ((01)14026704341433(17)260428(10)KME21E1264), 112082075, KME21F0184 ((01)14026704341433(17)260528(10)KME21F0184), 112082075, KME21F0385 ((01)14026704341433(17)260528(10)KME21F0385), 112082075, KME21F0594 ((01)14026704341433(17)260528(10)KME21F0594), 112082075, KME21F0725 ((01)14026704341433(17)260528(10)KME21F0725), 112082080, KME21D2012 ((01)14026704341440(17)260328(10)KME21D2012), 112082080, KME21F0981 ((01)14026704341440(17)260528(10)KME21F0981), 112082080, KME21D1653 ((01)14026704341440(17)260328(10)KME21D1653), 112082080, KME21D1946 ((01)14026704341440(17)260328(10)KME21D1946), 112082080, KME21D2011 ((01)14026704341440(17)260328(10)KME21D2011), 112082080, KME21E0584 ((01)14026704341440(17)260428(10)KME21E0584), 112082080, KME21E0687 ((01)14026704341440(17)260428(10)KME21E0687), 112082080, KME21E1452 ((01)14026704341440(17)260428(10)KME21E1452), 112082080, KME21E0770 ((01)14026704341440(17)260428(10)KME21E0770), 112082080, KME21F1006 ((01)14026704341440(17)260528(10)KME21F1006), 112082085, KME21E0902 ((01)14026704341457(17)260428(10)KME21E0902), 112082085, KME21E1291 ((01)14026704341457(17)260428(10)KME21E1291), 112082085, KME21F0741 ((01)14026704341457(17)260528(10)KME21F0741), 112082095, KME21E1393 ((01)14026704341471(17)260428(10)KME21E1393); c. Product Code, Batch Number (UDI): 112482065LA, KME21E0467 ((01)14026704629142(17)260428(10)KME21E0467), 112482070LA, KME21E0450 ((01)14026704629159(17)260428(10)KME21E0450), 112482075LA, KME21E0372 ((01)14026704629166(17)260428(10)KME21E0372), 112482075LA, KME21E0378 ((01)14026704629166(17)260428(10)KME21E0378), 112482075LA, KME21E0451 ((01)14026704629166(17)260428(10)KME21E0451), 112482075LA, KME21E0489 ((01)14026704629166(17)260428(10)KME21E0489), 112482080LA, KME21E0381 ((01)14026704629173(17)260428(10)KME21E0381), 112482085LA, KME21F0101 ((01)14026704629180(17)260528(10)KME21F0101), 112482085LA, KME21E0779 ((01)14026704629180(17)260428(10)KME21E0779),112482085LA, KME21E0956 ((01)14026704629180(17)260428(10)KME21E0956), 112482085LA, KME21F0520 ((01)14026704629180(17)260528(10)KME21F0520), 112482085LA, KME21F0637 ((01)14026704629180(17)260528(10)KME21F0637), 112482095LA, KME21E0742 ((01)14026704629203(17)260428(10)KME21E0742), 112482100LA, KME21D1667 ((01)14026704629210(17)260328(10)KME21D1667)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1011-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1010-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-23
Z-1011-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-23
Z-1012-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-23

Product code BTR

K961837Class IIRush Oral/nasal Tracheal Tube Cuffed Magill/murphyRusch Intl. / cleared 1996-08-16

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)