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SAFELINE set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. UNIVERSAL IV ADMIN SET; Catalog Number: 352604. 2. SAFELINE ADDITIV ALTVTD 3 INJ S; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1251. 3. SAFELINE PED. ADDITIVE; Primary Gravity IV Set with 3 SafeLine Injection Sites; Catalog Number: NF1290. Class II

Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B Braun Medical Inc 20251029 Ongoing
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
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SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADM SET 15 DR W/2 SAFEDAY & STOPCOCK; Catalog Number: 352646. Class II

Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B Braun Medical Inc 20251029 Ongoing
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
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SafeDAY set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET 60 DROP W/2 SAFEDAY; Catalog Number: 352635. Class II

Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B Braun Medical Inc 20251029 Ongoing
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
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RATE FLOW set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. RATEFLOW ADMIN 15 DROP W/2 CARESITES; Catalog Number: 375258. Class II

Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B Braun Medical Inc 20251029 Ongoing
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
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Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DROP W/2 CARESITE; Catalog Number: 354212. Class II

Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B Braun Medical Inc 20251029 Ongoing
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
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Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.; Catalog Number: 490564. Class II

Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B Braun Medical Inc 20251029 Ongoing
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
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Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK IV SET 15DROP W/3 CARESITE; Catalog Number: 354213. Class II

Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B Braun Medical Inc 20251029 Ongoing
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
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Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET,3 CARESITE LADS,115 IN.; Catalog Number: 490361. Class II

Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B Braun Medical Inc 20251029 Ongoing
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
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IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. AESTHESIA IV SET, 127 in.; Catalog Number: 490551. Class II

Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B Braun Medical Inc 20251029 Ongoing
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
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IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET, 129 IN, 3 CARESITE LADS; Catalog Number: 490225. Class II

Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

B Braun Medical Inc 20251029 Ongoing
Distributed: Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
View Details
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