EPA (Environmental Protection Agency)
1 records
epa_echo
1 records
fda
11 records
FDA Recall: Trinity Sterile, Inc. — Class II
20250129
Potential for hole in package compromising sterility of the medical kit. | Product: Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa & Statlock CS/30 Mode
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FDA Device Recall: Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa &
2025-01-29
Class II — Potential for hole in package compromising sterility of the medical kit.
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FDA Device Recall: Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL
2025-01-29
Class II — Potential for hole in package compromising sterility of the medical kit.
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FDA Device Recall: Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegade
2025-01-29
Class II — Potential for hole in package compromising sterility of the medical kit.
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FDA Device Recall: Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressin
2025-01-29
Class II — Potential for hole in package compromising sterility of the medical kit.
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FDA Recall: Trinity Sterile, Inc. — Class II
20220824
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those wit | Product: Sklar Instruments IV Cath Dressing Tra...
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FDA Recall: Trinity Sterile, Inc. — Class II
20220824
Kits mislabeled as latex-free, the packaging for component 94-7002 Non-Adherent Dressing contains natural rubber latex. Potential risk to to those wit | Product: Wolf Pak Premium Dressing Change Kit w...
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FDA Device Recall: Sklar Instruments IV Cath Dressing Tray Cs/25 Re-Order Number: 96-1708
2022-08-24
Class II — 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
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FDA Device Recall: Wolf Pak Premium Dressing Change Kit with GuardVA and Statlok Cs/30 Ref: DC5090
2022-08-24
Class II — 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
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FDA Device Recall: Wolf Pak Premium Dressing Change Kit with Statlock CS/30 Ref: DC5040LF
2022-08-24
Class II — 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
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FDA Device Recall: Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to
2021-04-28
Class II — Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
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