Recall Z-1010-2023 ยท BTR Tube, Tracheal (W/Wo Connector)
TELEFLEX LLC
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
| Date | Jan 23, 2023 (initiated Dec 8, 2022) |
| Status | Open, Classified |
| 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 o |
| 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, Belg |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K780900 | SLICK SET Polamedco, Inc., Jul 17, 1978 |