Home / Recalls / TELEFLEX LLC / Z-1010-2023

Z-1010-2023 Class II Ongoing

Recalled by TELEFLEX LLC — Morrisville, NC

Recall Details

Product Type
Devices
Report Date
February 1, 2023
Initiation Date
December 8, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,270 units

Product Description

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation

Reason for Recall

Potential for pilot balloon non-inflation or cuff non-deflation.

Distribution Pattern

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.

Code Information

a. Product Code: 170060, Batch Number: KME21E1411, UDI: (01)04026704319558(17)260428(10)KME21E1411; b. Product Code: 170070, Batch Number (UDI): KME21D1430 ((01)04026704319572(17)260328(10)KME21D1430), KME21E1290 ((01)04026704319572(17)260428(10)KME21E1290); c. Product Code: 170075, Batch Number: KME21D1785, UDI:(01)04026704319589(17)260328(10)KME21D1785; d. Product Code: 170080, Batch Number (UDI): KME21D1204 ((01)04026704319596(17)260328(10)KME21D1204), KME21E1287 ((01)04026704319596(17)260428(10)KME21E1287); e. Product Code: 170085, Batch Number: KME21E1296, UDI:(01)4026704319602(17)260428(10)KME21E1296; f. Product Code: 170090, Batch Number: KME21E1232, UDI: (01)4026704319619(17)260428(10)KME21E1232

Other recalls by TELEFLEX LLC

  • Z-1882-2023 Class I — Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 1120800 (May 25, 2023)
  • Z-1867-2023 Class I — Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180060 (May 25, 2023)
  • Z-1927-2023 Class I — Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380035 (May 25, 2023)
  • Z-1861-2023 Class I — Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180030 (May 25, 2023)
  • Z-1874-2023 Class I — Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030 (May 25, 2023)
  • Z-1834-2023 Class I — Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085 (May 25, 2023)
  • Z-1877-2023 Class I — Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, (May 25, 2023)
  • Z-1865-2023 Class I — Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050 (May 25, 2023)
  • Z-1945-2023 Class I — Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, (May 25, 2023)
  • Z-1950-2023 Class I — Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, (May 25, 2023)