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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 AD.SET W/15 DR 128 IN, EXT SET 9 IN; Catalog Number: 490301. 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, 15DR, CARESITE LAD, 130 IN; Catalog Number: 477002. 2. IV ADMIN SET 85 IN.; Catalog Number: 477017. 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. NF1500UP, IV ADMINISTRATION SET; Catalog Number: 490070. 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. NF1505, IV ADMIN SET W/2 H.F. STOPCOCKS; Catalog Number: 490088. 2. IV ADMIN SET W/2 SAFELINE & HF STOPCOCK; Catalog Number: 490107. 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 103 IN.; Catalog Number: 490239. 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 3 CARESITE LADS, 131 IN.; Catalog Number: 490274. 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 W/15 DROPS/ML, 128 IN.; Catalog Number: 480231. 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 W/ 15 DROPS/ML, 118 IN.; Catalog Number: 490437. 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 15DR HF 4-WAY STPCK 135 IN.; Catalog Number: 490193. 2. IV AD SET, 2 CARESITE, SAFEPORT, 134 IN.; Catalog Number: 490326. 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 124 IN.; Catalog Number: 490451. 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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