SafeDAY set 352635 recalled over piggyback backflow and inability to prime
B. Braun Medical is recalling 200,917 SafeDAY 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
SafeDAY 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 352635.
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 200,917 units carrying primary UDI-DI 04046955594948. 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
- SafeDAY 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 60 DROP W/2 SAFEDAY; Cat
- 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 (4)
- 1. Catalog Number: 352635
- Primary UDI-DI: 04046955594948
- Unit of Dose UDI-DI: 04046955594931
- Expiration Date: 36mths from Start Date.
Distribution
Distribution scope not specified by the agency.
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