Westmed Flex Extenders recalled for connector failure risk
Westmed is recalling Flex Extenders because connectors may fail to hold properly, potentially causing the breathing circuit to leak or disconnect and creating life-threatening conditions. Over 50,000 units are affected across multiple U.S. states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device that could cause life-threatening conditions or death if the connector fails during use. However, no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score at most 3.
Plain-English summary
Westmed, Inc. is recalling certain Flex Extenders (catalog numbers S6411P and 7 5132). These are non-invasive, single-use, disposable plastic connectors that join breathing circuits to patient interfaces such as tracheal tubes, tracheostomy tubes, or masks. A total of 50,050 units have been distributed across multiple U.S. states.
The connectors are subject to recall because they do not meet manufacturing specifications, resulting in insufficient connection force. Consequently, the connector may leak or disconnect during use. A disconnection or leak could cause life-threatening conditions or death.
The affected devices were distributed in 30 U.S. states: Alaska, California, Colorado, DC, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Vermont, Washington, and West Virginia. Specific lot numbers have been identified for both catalog numbers.
The recalled product
- Product
- 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 conne
- Manufacturer
- Westmed, Inc.
- Affected units
- 50,050
Distribution
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