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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