[Recalled] HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology. — Potential for the outer bag having pinhole leaks near the seal, which may resul… | FDA 2022-12-15

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Stradis Healthcare

• McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution. — Class II
• HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology. — Class II
• HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology. — Class II
• VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS — Class II
• Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare. — Class II
• HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.