Reported Apr 28, 2021 · Terminated

Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter…

Trinity Sterile, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Trinity Sterile, Inc. · 201 Kiley Dr · Salisbury, MD · 21801-2249

Is this the product you have?

  • Midline Catheter Dressing Change
  • Kit with Statlock - Product UsageIntended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing)
  • Product NumberTRIO0000l
Lot codes and dates
  • Lot Number600001
  • UDI(01)00841767107942(17)2022-04- 30(10)600001
Amount recalled
2970 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 16, 2023 · Data as of Sep 19, 6:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.