Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for Extension Set utilized in gravity IV administration sets and pump administration sets utilized wi... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for Extension Set utilized in gravity IV administration sets and pump administration sets utilized wi... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for Extension Set utilized in gravity IV administration sets and pump administration sets utilized wi... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for Extension Set utilized in gravity IV administration sets and pump administration sets utilized wi... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for Extension Set utilized in gravity IV administration sets and pump administration sets utilized wi... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for Extension Set utilized in gravity IV administration sets and pump administration sets utilized wi... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for Extension Set utilized in gravity IV administration sets and pump administration sets utilized wi... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for Infusomat utilized in gravity IV administration sets and pump administration sets utilized with B... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for IV Administration Set utilized in gravity IV administration sets and pump administration sets uti... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for IV Administration Set utilized in gravity IV administration sets and pump administration sets uti... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for IV Administration Set utilized in gravity IV administration sets and pump administration sets uti... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for IV Administration Set utilized in gravity IV administration sets and pump administration sets uti... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for IV Administration Set utilized in gravity IV administration sets and pump administration sets uti... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for IV Administration Set utilized in gravity IV administration sets and pump administration sets uti... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for IV Administration Set utilized in gravity IV administration sets and pump administration sets uti... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for IV Administration Set utilized in gravity IV administration sets and pump administration sets uti... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for IV Administration Set utilized in gravity IV administration sets and pump administration sets uti... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for IV Administration Set utilized in gravity IV administration sets and pump administration sets uti... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for IV Administration Set utilized in gravity IV administration sets and pump administration sets uti... Oct 29, 2025 FDA device enforcement
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II Reported ongoing
Distribution: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
Official source for IV Administration Set utilized in gravity IV administration sets and pump administration sets uti...