Agency classClass IIOur severity:High FDA (Devices)·Z-0938-2023·Announced 2023-01-18

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.

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: 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
Category: Medical Device — Sterile Syringe Kit
Hazard: sterility-breach
pinhole-leak
contamination-risk
Affected units: 112,675

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.

The notice also names 10 states specifically:

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.

See all 18 products in this recall →

Same manufacturer · Stradis Healthcare

See all →

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HCT 6 CC Syringe Kits recalled for potential sterility breach from packaging leaks
FDA (Devices) · 2023-01-18
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Fluid Filter Transfer Kit Recalled Over Potential Sterility Breaches
FDA (Devices) · 2023-01-18
High
PHS Lacertaion Tray Sterile Kit Recall Due to Seal Leakage Risk
FDA (Devices) · 2023-01-18

Same hazard · sterility breach