Syringe Kit Recall: Potential Sterility Breach from Outer Bag Leaks
Stradis Healthcare is recalling HCT 12 CC Syringe Kits due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 112,675 units distributed nationwide.
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 potential for sterility breach of a medical device. No illnesses or injuries reported; hazard is theoretical based on manufacturing defect, placing this at the maximum for theoretical-harm recalls.
Plain-English summary
Stradis Healthcare is recalling HCT 12 CC Syringe Kits distributed by Health Care Technology. The recall covers 112,675 units of sterile syringe kits with 10 specific lot numbers affected.
The recall is due to potential pinhole leaks that may develop near the seal of the outer bag. These leaks could compromise the sterility assurance of the syringe kit, potentially exposing the contents to contamination.
The affected kits were distributed nationwide, including to facilities in Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington. Healthcare facilities and providers who have received these kits should check their inventory against the lot numbers listed in this recall notice.
If you have kits from the affected lot numbers, discontinue use and contact the manufacturer or distributor for replacement or return instructions. No illnesses or injuries have been reported as of this recall announcement.
The recalled product
- Product
- HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
- Manufacturer
- Stradis Healthcare
- Hazard
- sterility-breach
- pinhole-leak
- contamination-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 (12)
- Assembly Number HCT3548-2
- UDI-DI: M752HCT354821
- Lot Numbers: 222770947
- 221809694
- 221938965
- 221748547
- 221578546
- 221808445
- 221386002
- 222859338
- 222940522
- 221938972
Distribution
Distributed nationwide across the United States.
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