Anesthesia set 490469 recalled over backflow and priming occlusion
B. Braun Medical is recalling 104,784 units anesthesia iv sets over the potential for medication backflow from secondary piggyback containers and an inability to prime.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
Anesthesia IV 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 490469.
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 104,784 units carrying primary UDI-DI 04046964958816. 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
- Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedure.
- Manufacturer
- Noah Medical Corporation
- Affected units
- 47
Distribution
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