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Recall Observatory FDA recall evidence

Device product

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

Z-1010-2023

December 08, 2022

Class II

Product summary

Firm
TELEFLEX LLC
Event
Event 91301
Status
Ongoing
Classification
Class II
Quantity
2,270 units
Official record key
device-enforcement:Z-1010-2023

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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