Trinity Sterile, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1468-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l

Product Classification:

Class II

Date Initiated: February 23, 2021

Date Posted: April 28, 2021

Recall Number: Z-1468-2021

Event ID: 87538

Reason for Recall:

Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility

Status: Terminated

Product Quantity: 2970 units

Code Information:

Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001

Distribution Pattern:

US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.

Voluntary or Mandated:

Voluntary: Firm initiated