Posi-Stop Injection Needles recalled for manufacturing debris blockage
Hobbs Medical is recalling Posi-Stop Injection Needles due to manufacturing debris that can block needle flow. Some units may contain debris in the inner sheath that prevents injection solutions from functioning properly.
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: FDA Class II recall with a manufacturing defect that renders the device completely non-functional by blocking injection solution flow. Although no illnesses or injuries have been reported, this is a risk-of-harm product where treatment failure could occur, meeting the rubric criterion for High severity.
Plain-English summary
Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles, 25 Gauge (Catalog Number 4704), due to a manufacturing defect. Specific lot numbers affected are H10-23-106 and H11-23-059.
Some units were found to contain debris from the manufacturing process within the needle's inner sheath. This debris blocks the needle's inner diameter, preventing injection solutions from flowing through the needle tip as intended, resulting in non-functional needles that cannot deliver medication.
The affected units were distributed nationwide in the United States (Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin, and West Virginia) as well as Canada.
Users who have received potentially affected Posi-Stop Injection Needles should stop use immediately and contact Hobbs Medical, Inc. for instructions regarding device return or replacement.
The recalled product
- Product
- Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- manufacturing-debris
- needle-blockage
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog Number: 4704
- UDI-DI: M84947040
- Lot Numbers: H10-23-106
- H11-23-059.
Distribution
Distributed nationwide across the United States.
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