Extension set 490234 recalled over piggyback backflow and occlusion risk
B. Braun Medical is recalling 27,480 extension 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
Extension 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 490234.
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 27,480 units carrying primary UDI-DI 04046964716362. 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
- 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 ULTRAPORT STOPCOCK, 37IN.;
- Manufacturer
- B Braun Medical Inc
- Affected units
- 27,480
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 (3)
- 1. Catalog Number: 490234
- Primary UDI-DI: 04046964716362
- Unit of Dose UDI-DI: 04046964716355.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 116 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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