Stradis Healthcare: Medical Device Recall in 2023 - (Recall #: Z-0935-2023)

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:

PICC KIT, 10/CS, ACCESS MEDICAL LABEL

Product Classification:

Class II

Date Initiated: December 15, 2022
Date Posted: January 18, 2023
Recall Number: Z-0935-2023
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: 180 units
Code Information:

Assembly Number ACC-2550, UDI-DI: M752ACC25501, Lot Number: 220241506

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