Westmed, Inc.: 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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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 Quantity: 50,050 units Lot/code info: 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

UPC codes

00709078012488, 10709078012485, 00709078008405, 10709078008402

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.