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

Recall number

Z-1010-2023

Recalling firm

TELEFLEX LLC

Product

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

Status

Open, Classified

Initiated

2022-12-08

Posted

2023-01-23

Terminated

not on file

Reason

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

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 recalls@teleflex.com. 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

2,270 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.

Lot, serial or model codes

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

510(k) numbers

["K780900"]

PMA numbers

not on file

Product code

BTR

Firm FEI

3005747797

Firm city

Morrisville

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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