HCT 6 CC Syringe Kits recalled for potential sterility breach from packaging leaks
Stradis Healthcare recalls 76,260 HCT 6 CC Syringe Kits due to potential pinhole leaks in outer packaging that may compromise sterility. The kits were distributed nationwide.
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: Class II medical device recall with potential for sterility breach due to packaging defect. While no illnesses or injuries have been reported and the hazard is theoretical, potential contamination of a sterile medical device used in healthcare poses a risk of harm.
Plain-English summary
Stradis Healthcare, in coordination with Health Care Technology, is recalling 76,260 units of the HCT 6 CC Syringe Kit. The kits are distributed in cases of 5 bags, with 4 trays per bag and 25 units per tray.
The recall is due to a potential for pinhole leaks near the seal of the outer bag. These leaks could compromise the sterility of the syringe kit, which is critical for safe medical use.
The recalled products were distributed nationwide in Florida, Illinois, Indiana, Massachusetts, Mississippi, Nevada, Ohio, Tennessee, Texas, and Washington. The affected lot numbers are: 222491279, 220113056, 222782510, 221306003, 220051819, 222149971, 222210292, 221245035, and 221458554.
Healthcare facilities and providers who have received these kits should verify the lot numbers and discontinue use if products match the recall. Contact the manufacturer or distributor for guidance on returns or replacement.
The recalled product
- Product
- HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
- Manufacturer
- Stradis Healthcare
- Affected units
- 76,260
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 (11)
- Assembly Number HCT3916-1
- UDI-DI: M752HCT391611
- Lot Numbers: 222491279
- 220113056
- 222782510
- 221306003
- 220051819
- 222149971
- 222210292
- 221245035
- 221458554
Distribution
Part of a larger recall action
This product is one of 18 recalled by 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.
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