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Extension 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. EXTENSION SET W/ B/C VALVE 53 in.; Catalog Number: 490358. 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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Extension 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. EXT SET W/ B/C VLV, ULTRAPORT, 57 IN.; Catalog Number: 490202. 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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Extension 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. EXTENSION SET, 25 IN.; Catalog Number: 490629. 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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Extension 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 numbers: 1. EXTENSION SET, 18 IN; Catalog Number: 490448. 2. EXTENSION SET, 52 IN.; Catalog Number: 490465. 3. EXTENSION SET 49 IN.; Catalog Number: 490486. 4. EXTENSION SET, 12 CARESTITE LADS; Catalog Number: 490577. 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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Extension 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. ANES SET W/DUAL FEM.LL SAFEPORT MANIFOLD; Catalog Number: 456520. 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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Extension 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. ET08US EXTENSION SET W/ULTRA Y SITE; Catalog Number: 474912. 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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Extension 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. AS152V2DLL; Catalog Number: 473309. 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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Caresite 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. Primary Gravity Filtered Set with 2 CARESITE¿ Injection Sites; IV ADM 15 DROP W/2 CARESITE FILTER; Catalog Number: 354207. 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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Caresite 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 numbers: 1. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/2 CARESITE; Catalog Number: 354202. 2. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADM 15DROP W/2 CARESITE SLIDECLMP; Catalog Number: 354203. 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
Caresite 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 numbers: 1. Primary Gravity IV Set with 2 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/2 CARESITE; Catalog Number: 354204. 2. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 15 DROP W/3 CARESITE; Catalog Number: 354205. 3. Primary Gravity IV Set with 3 CARESITE¿ Injection Sites; IV ADMIN SET 60 DROP W/3 CARESITE; Catalog Number: 354206. 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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