Stradis Healthcare: Medical Device Recall in 2023 - (Recall #: Z-0946-2023)

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 Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

Product Classification:

Class II

Date Initiated: December 15, 2022

Date Posted: January 18, 2023

Recall Number: Z-0946-2023

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: 275 units

Code Information:

Assembly Number TM.SCP1ML, UDI-DI: M752TMSCP1ML0, Lot Numbers: 222270319, 220834335

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