FDA-Device2021-04-28Class II
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
Trinity Sterile, Inc.
Hazard
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Sold states
US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.
Affected count
2970 units
Manufactured in
201 Kiley Dr, N/A, Salisbury, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1468-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief