Trinity Sterile, Inc. recall records

5 reported ongoing

9 records in this archive. Latest source date Dec 13, 2024.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A Product Description: Dressing cha...

Potential for hole in package compromising sterility of the medical kit.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of MD, PA, TN and TX.

Official source for Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model...
FDA device enforcement

Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product...

Potential for hole in package compromising sterility of the medical kit.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of MD, PA, TN and TX.

Official source for Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One St...
FDA device enforcement

Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N...

Potential for hole in package compromising sterility of the medical kit.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of MD, PA, TN and TX.

Official source for Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL ...
FDA device enforcement

Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Model/Catalog Number: DC5090LF Software Version: N/A Product Description: Dressing ...

Potential for hole in package compromising sterility of the medical kit.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of MD, PA, TN and TX.

Official source for Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Mod...
FDA device enforcement

Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 2...

Potential for hole in package compromising sterility of the medical kit.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of MD, PA, TN and TX.

Official source for Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6...

Reasons in these listed records

  • Potential for hole in package compromising sterility of the medical kit.
  • Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those with latex allergy

These examples come from this result page and are not a ranking of every recall reason.

Checking Trinity Sterile, Inc.

Is there a recall on trinity sterile, inc. right now?

This archive contains 9 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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