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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 ADM 15 DROP W/3 CARESITE N/C DUAL; Catalog Number: 354211. 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, 126 IN.; Catalog Number: 490488. 2. IV ADMIN SET W/15 DROPS/ML, 132 IN.; Catalog Number: 490492. 3. IV ADMIN SET W/15 DROPS/ML, 139 IN.; Catalog Number: 490503. 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/10 DROPS, 138 IN.; Catalog Number: 490426. 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. NF1503 15 DR UNIV SPIKE, INJ SITE, BCV; Catalog Number: 490062. 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. PB1500 15 DROP IV SET W/2 STOPCOCKS; Catalog Number: 490025. 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 15D, 2 CARESITES, 153 IN.; Catalog Number: 490542. 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. 15DR 2SAFELINE 1CARESITE 1STOPCOCK 131IN; Catalog Number: 490612. 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, 133 IN.; Catalog Number: 490245. 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. Catalog Number: 490549; Primary UDI-DI: 04046955270323; Unit of Dose UDI-DI: 04046955270316; Expiration Date: Earliest Exp of Comp or 36mths. 2. Catalog Number: 490565; Primary UDI-DI: 04046955275601; Unit of Dose UDI-DI: 04046955275595; Expiration Date: Earliest Exp of Comp or 36mths. 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 ADMINISTRATION SET WITH 15 DROPS/ML; Catalog Number: 490507. 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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