IV set 490385 recalled over medication backflow between IV containers
B. Braun Medical is recalling 168,816 units iv administration sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: medication backflow between IV containers can alter what a patient receives, and no injuries are reported.
Plain-English summary
IV Administration Sets used in gravity IV administration and with B. Braun's Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump are being recalled, including catalog number 490385.
The recall follows the potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers, and the inability to prime the set due to occlusion.
The recall covers 168,816 units carrying primary UDI-DI 04046964730146. Distribution was worldwide, including the United States and internationally to Canada, Germany, Guatemala and Singapore. The FDA has classified the action as Class II.
Backflow can move a secondary medication into the primary bag, and a set that cannot be primed cannot be used. The enforcement record reports no injuries. Facilities should quarantine affected lots and follow B. Braun's instructions.
The recalled product
- Product
- 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 numbers: 1. IV ADMIN SET, 10 DROPS/ML,
- Manufacturer
- B Braun Medical Inc
- Hazard
- backflow
- occlusion
- priming-failure
- infusion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 1. Catalog Number: 490385
- Primary UDI-DI: 04046964730146
- Unit of Dose UDI-DI: 04046964730139. 2. Catalog Number: 490401
- Primary UDI-DI: 04046964761416
- Unit of Dose UDI-DI: 04046964761409.
Distribution
Distribution scope not specified by the agency.
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