Stradis Healthcare: Medical Device Recall in 2023 - (Recall #: Z-0947-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.

Product Classification:

Class II

Date Initiated: December 15, 2022

Date Posted: January 18, 2023

Recall Number: Z-0947-2023

Event ID: 91350

Reason for Recall:

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

Status: Ongoing

Product Quantity: 600 units

Code Information:

Assembly Number TM8823-1, UDI-DI: M752TM882310, Lot Number: 220110674

Distribution Pattern:

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Voluntary or Mandated:

Voluntary: Firm initiated