United StatesADDitIV and Anesthesia IV sets used in gravity IV administration sets and pump administration sets with B. Braun Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump are affected; they are identified by multiple catalog numbers such as V1443, V1447, V1448, V1484, 352447, 352062, 490189, 490226, 490469, 490470, 490467, 490477 and many others listed. They were recalled due to a potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
What's being recalled
ADDitIV 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, 2 Non-Needle-Free Injection Sites; Catalog Number: V1443. 2. ADDITIVE SET W/ 3 INJ SITES -DR*; Catalog Number: V1447. 3. ADD PEDIATRIC 3 INJ LUER LOCK; Catalog Number: V1448. 4. ADULT ADD 2 INJ CKV LUER LOCK; Catalog Number: V1484.
ADDitIV 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. V1782F UNIV IV SET W/0.2 MICRON FILTER; Catalog Number: 352447.
ADDitIV 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. PB602VSL NON-VENT SET 103-IN-DR; Catalog Number: 352062.
Anesthesia IV 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, 108 IN; Catalog Number: 490189. 2. IV ADMIN SET 137 IN.; Catalog Number: 490226.
Anesthesia IV 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, 132 IN; Catalog Number: 490469. 2. IV ADMIN SET, 60D 2 CARESITE VLV, 132 IN; Catalog Number: 490470.
Anesthesia IV 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,15 DROPS/ML, W/EXT SET; Catalog Number: 490467.
Anesthesia IV 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, 134 IN.; Catalog Number: 490477.
Anesthesia IV 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, 144 IN.; Catalog Number: 490472.
Anesthesia IV 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, 15 DROPS/ML 125 IN; Catalog Number: 490452.
Anesthesia IV 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 CARESITE LAD, 126 IN; Catalog Number: 490444.
Anesthesia IV 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, 2-HIGH FLOW STPCKS, 124 IN; Catalog Number: 490476.
Anesthesia IV 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 117 IN.; Catalog Number: 490468.
B.BRAUN 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/ 60 DROPS/ML,141 in.; Catalog Number: 490349.
Blood 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. Y-TYPE BLOOD SET 124 IN.; Catalog Number: 490196.
Blood 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. Y-TYPE BLOOD SET W/ 170 ?M FILTER 120 IN; Catalog Number: 490355.
And 101 more products.
Recalling firm: B Braun Medical Inc, Bethlehem, PA, United States.
How to identify it
1. Catalog Number: V1443; Primary UDI-DI: 04046964188350; Unit of Use UDI-DI: 04046964188343. 2. Catalog Number: V1447; Primary UDI-DI: 04046964188411; Unit of Use UDI-DI: 04046964188404. 3. Catalog Number: V1448; Primary UDI-DI: 04046964188435; Unit of Use UDI-DI: 04046964188428. 4. Catalog Number: V1484; Primary UDI-DI: 04046964188473; Unit of Use UDI-DI: 04046964188466. 1. Catalog Number: 352447; Primary UDI-DI: 04046964181665; Unit of Use UDI-DI: 04046964181658. 1. Catalog Number: 352062; Primary UDI-DI: 04046964181160; Unit of Use UDI-DI: 04046964181153. 1. Catalog Number: 490189; Primary UDI-DI: 04046964303586; Unit of Use UDI-DI: 04046964303579. 2. Catalog Number: 490226; Primary UDI-DI: 04046964304262; Unit of Use UDI-DI: 04046964304255. 1. Catalog Number: 490469; Primary UDI-DI: 04046964958816; Unit of Dose UDI-DI: 04046964958809. 2. Catalog Number: 490470; Primary UDI-DI: 04046964958830; Unit of Dose UDI-DI: 04046964958823. Catalog Number: 490467; Primary UDI-DI: 04046964958779; Unit of Dose UDI-DI: 04046964958762. Catalog Number: 490477; Primary UDI-DI: 04046964991271; Unit of Dose UDI-DI: 04046964991264. Catalog Number: 490472; Primary UDI-DI: 04046964958878; Unit of Dose UDI-DI: 04046964958861. Catalog Number: 490452; Primary UDI-DI: 04046964848933; Unit of Dose UDI-DI: 04046964848926. Catalog Number: 490444; Primary UDI-DI: 04046964848773; Unit of Dose UDI-DI:04046964848766. Catalog Number: 490476; Primary UDI-DI: 04046964958953; Unit of Dose UDI-DI:04046964958946. Catalog Number: 490468; Primary UDI-DI: 04046964958793; Unit of Dose UDI-DI: 04046964958786. Catalog Number: 490349; Primary UDI-DI: 04046964602405; Unit of Dose UDI-DI: 04046964602399. Catalog Number: 490196; Primary UDI-DI: 04046964303722; Unit of Dose UDI-DI: 04046964303715. Catalog Number: 490355; Primary UDI-DI: 04046964616013; Unit of Dose UDI-DI: 04046964616006. Catalog Number: 490530; Primary UDI-DI: 04046955203321; Unit of Dose UDI-DI: 04046955203314. Catalog Number: 490438…
The hazard
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US distribution and international distribution to Canada, Germany, Guatemala, and Singapore.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)