FDAClass IIJanuary 18, 2023

HCT CENTRAL LINE Insertion Tray recall: Sterility Concern

HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology

Why was HCT CENTRAL LINE Insertion Tray recalled?

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Assembly Number HCT8249CP-3, UDI-DI: M752HCT8249CP30, Lot Numbers: 222098152, 222551621, 221010141, 222309118, 222901807

Product
HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology
Recalling firm
Stradis Healthcare
Quantity
1,176 units
Distribution
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Recall date
January 18, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls