1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight connection between breathing circuits and patient interface (tracheal tube, tracheostomy tube, or mask).
Enforcement
- Recall Number
- Z-0263-2025
- Event ID
- 95453
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Westmed, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 6, 2024
- Initiation Date
- September 27, 2024
- Classification Date
- October 30, 2024
- Address
- 5580 S Nogales Hwy Ste 170, N/A, Tucson, AZ, 85706-3333, United States
Description
1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight connection between breathing circuits and patient interface (tracheal tube, tracheostomy tube, or mask).
Due to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may leak or disconnect and may cause life threating conditions or death.
Catalog Number: S6411P UDI-DI codes: Each: 00709078012488 Case: 10709078012485 Lot Numbers: 0004294660 0004289136 0004291318 0004295361 Catalog Number: 7 5132 UDI-DI codes: Each: 00709078008405 Case: 10709078008402 Lot Numbers: 0004289133 0004289134 0004289135 0004289735 0004289736 0004289737 0004290327 0004290328 0004291315 0004291316 0004291317 0004291790 0004291791 0004292272 0004292273 0004292275 0004292717 0004293127 0004294432 0004294433 0004295069 0004295358 0004295458
U.S.: AK, CA, CO, DC, FL, GA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TX, VA, VT, WA, and WV O.U.S.: N/A
50,050 units