FDA recall Z-1468-2021

Product

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

Reason for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-02-23

Report date

2021-04-28

Termination date

2023-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1468-2021