Stradis Healthcare Curved Tip Syringes Recalled Due to Incomplete Sterile Sealing
Stradis Medical is recalling approximately 300 Curved Tip Syringes because manufacturing defects may result in incomplete sealing of the sterile kit, potentially compromising product sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall for a sterile surgical product. While no illnesses or injuries have been reported, a breach in the sterile seal of surgical procedure kits represents a significant risk-of-harm product without injury yet reported, meeting the rubric criterion for High (3) severity.
Plain-English summary
Stradis Medical, LLC dba Stradis Healthcare is recalling Curved Tip Syringes, Item No. 60060GCTS (UDI/DI case: M75260060GCTS1, kit: M75260060GCTS0, Lot 22257490438). These products were distributed nationwide in the United States and Canada. Approximately 300 units are affected.
During manufacturing, certain conditions may have resulted in the outer bag of the sterile medical procedure kits being incompletely sealed. An incomplete seal may allow a breach in the sterility of the kit, potentially exposing the product to contamination.
No injuries or illnesses have been reported. Recipients of these syringes should discontinue use and contact Stradis Medical, LLC for guidance on product replacement or return instructions.
The recalled product
- Product
- STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Affected units
- 300
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)
- UDI/DI (case) M75260060GCTS1
- UDI/DI (kit)M75260060GCTS0
- Serial/Lot Numbers: 22257490438
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by Stradis Medical, LLC dba Stradis Healthcare 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.
See all 78 products in this recall →Related recalls
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