Tacy Medical Syringe Convenience Packs Recalled Due to Potential Sterility Loss
Tacy Medical syringe convenience packs may have pinhole leaks near the seal that compromise sterility. Affected lots 222270319 and 220834335 were distributed across 10 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 a Class II medical device recall involving sterile injection equipment with a potential for loss of sterility. While no illnesses or injuries have been reported to date, non-sterile syringes represent a clear risk of serious infection if used for injections, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Stradis Healthcare is recalling Tacy Medical Syringe Convenience Packs (sterile, 60 packs per bag, 5 bags per case) due to potential pinhole leaks near the seal that may result in a breach in the sterility of the kit. A total of 275 units were distributed across Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington.
Non-sterile syringes used for injections pose a risk of infection. The affected lots are 222270319 and 220834335, identifiable by Assembly Number TM.SCP1ML and UDI-DI M752TMSCP1ML0.
Healthcare providers and patients who have received or used affected syringe convenience packs should contact their healthcare provider to determine if they have received an affected product and discuss appropriate next steps.
The recalled product
- Product
- Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
- Manufacturer
- Stradis Healthcare
- Hazard
- sterility-breach
- infection-risk
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)
- Assembly Number TM.SCP1ML
- UDI-DI: M752TMSCP1ML0
- Lot Numbers: 222270319
- 220834335
Distribution
Distributed nationwide across the United States.
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