Lower riskMedical device recall · FDA · Published February 23, 2021
Trinity Sterile Midline Catheter Dressing Kit: Risk of Infection from Improper Sealing
Trinity Sterile recalls Midline Catheter Dressing Change Kits with Statlock due to face masks or materials in the seal, risking infection. Affected kits have Product Number TRIO0000l and Lot Number 60:0001.
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Take action
Contact the company
📍Recalling firmTrinity Sterile, Inc.201 Kiley Dr · Salisbury, MD 21801-2249
✎ GovInfoNow plain-language explainer
Trinity Sterile is recalling Midline Catheter Dressing Change Kits with Statlock because some kits have face masks or other materials in the seal, which can cause improper sealing and compromise sterility. This risk could lead to infections if the catheter is not properly maintained. Read more at govinfonow.com/recall/63241-trinity-sterile-midline-catheter-dressing-kit-risk-of-infection-from.
“Trinity Sterile Midline Catheter Dressing Kit: Risk of Infection from Improper Sealing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63241-trinity-sterile-midline-catheter-dressing-kit-risk-of-infection-from. Based on FDA recall #Z-1468-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1468-2021%22&limit=1).
The FDA announced on Feb. 23, 2021, that Trinity Sterile, Inc. is recalling Midline Catheter Dressing Change Kits with Statlock due to compromised sterility caused by debris in the seals. The agency issued recall number Z-1468-2021 for the Class II voluntary recall.
How to tell if you have it
Brand: Trinity Sterile
Product: Midline Catheter Dressing Change Kit with Statlock
UPC: 00841767107942
Lot Number: 600001
Quantity: 2970 units
The hazard
The kits contain evidence of face masks or other material in the seal, causing improper seals and compromised sterility. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Trinity Sterile, Inc. has two other recalls on record since June 29, 2022. Other recent recalls of similar products include IMed Products Dressing Change Kit Recall (Dec. 13, 2024) and Sklar Instruments IV Cath Dressing Tray Cs/25 Recall (June 29, 2022). Additional similar product recalls include Medline Convenience Kits Recall (June 12, 2026), Medline IV Start Kits Recalled Due to Sterility Risk in Packaging (June 12, 2026), and Medline ARTERIAL LINE INSERTION KIT Recall (June 12, 2026).
How to tell if you have this one
Check for Product Number TRIO0000l and Lot Number 600001 on the kit packaging. The kits were sold starting April 30, 2022.
Brand
Trinity Sterile
Product
Midline Catheter Dressing Change Kit with Statlock
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Packaging
Look for Product Number TRIO0000l and Lot Number 600001 on the kit packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Iowa, Minnesota, Mississippi, Missouri, Nebraska, New York, Ohio, Oklahoma, Texas, Virginia.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1468-2021 (February 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1468-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.