Outlook set 354214 recalled over backflow and inability to prime
B. Braun Medical is recalling Outlook set catalog number 354214 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
Outlook 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 354214.
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 record lists the quantity as 0. The product carries primary UDI-DI 04046964182235 and was distributed 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
- Outlook 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. OUTLOOK IV SET 15DR W/2 CARESITE…
- Manufacturer
- B Braun Medical Inc
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: 354214
- Primary UDI-DI: 04046964182235
- Unit of Dose UDI-DI: 04046964182228
- Expiration Date: Earliest Exp of Comp or 36mths.
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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