Hobbs Posi-Stop Injection Needle Recall - Incorrect Expiration Date
Hobbs Medical is recalling Posi-Stop Injection Needles due to incorrect expiration dates on device labels that extend shelf life. Devices distributed between March 2018 and September 2020 could be used beyond their actual expiration.
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: Class II medical device recall with no reported illnesses or injuries. Incorrect expiration date represents a risk-of-harm to device sterility and integrity if used beyond actual shelf life, meeting High severity criteria.
Plain-English summary
Hobbs Medical, Inc. is recalling Posi-Stop Injection Needles (Catalog Number 4712) due to incorrect expiration dates displayed on device labels. The labeling error extends the shelf life of the affected devices, potentially allowing use beyond their actual expiration dates.
The affected devices were distributed in the United States and internationally (Canada, Austria, Belgium, Finland, and Norway) between March 25, 2018 and September 28, 2020. The affected products have lot numbers ending in "R" or are kits containing at least one device with a lot number ending in "R." The incorrect expiration dates on affected devices range from November 1, 2022 to September 1, 2025.
If you have an affected device, do not use it if the actual shelf life has expired. Contact Hobbs Medical, Inc. or your healthcare provider for instructions on how to verify whether your device is affected and what steps to take.
The recalled product
- Product
- Hobbs Posi-Stop Injection Needle Catalog Number: 4712
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 6
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 (1)
- UDI-DI: M84947120 Lot Numbers: H04-15-157R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 61 recalled by Hobbs Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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