Posi-Stop Injection Needle Recall Due to Manufacturing Debris
Hobbs Medical is recalling Posi-Stop Injection Needles (23 Gauge, Catalog 4706) due to manufacturing debris in the inner sheath that can block the needle and prevent injection solution flow.
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 a risk-of-harm medical device with a manufacturing defect that impairs its intended function. FDA Class II designation and the absence of reported illnesses or injuries support a High severity rating per the established rubric.
Plain-English summary
Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles, 23 Gauge, Catalog Number 4706, Lot Number SD09-23-089. The recalled product consists of 6 units distributed nationwide in Connecticut, Georgia, Indiana, Michigan, Minnesota, Mississippi, New Hampshire, New Jersey, New York, Ohio, Tennessee, Vermont, Washington, Wisconsin, West Virginia, and in Canada.
The recall was issued because some units contain debris from the manufacturing process within the inner sheath of the needle. This debris blocks the needle's inner diameter, preventing injection solutions from flowing as intended.
Patients and healthcare providers who have this product should contact Hobbs Medical, Inc. for recall information and instructions for replacement. If you have concerns about treatment with the recalled needles, consult your healthcare provider.
The recalled product
- Product
- Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- manufacturing-debris
- injection-failure
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 (3)
- Catalog Number: 4706
- UDI-DI: M84947060
- Lot Number: SD09-23-089.
Distribution
Distributed nationwide across the United States.
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