B. Braun AccuFlo Elastomeric Infusion Pump Recalled for Flow Rate Issues
B. Braun Medical is recalling AccuFlo Elastomeric Infusion Pumps because internal testing found flow rates outside specifications, which may cause overly rapid medication infusion.
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: The recall involves a medical device with a defect that may result in overly rapid infusion of medications, posing a risk of harm where injury has not yet been reported.
Plain-English summary
B. Braun Medical, Inc. is recalling 30,240 units of the AccuFlo CT-2000-100 Elastomeric Infusion Pump. The affected units are catalog number CT-2000-100, lots 3H0125F151 and 3H0225F151, with an expiration date of 7/2018. These devices are generally used for the delivery of antibiotic and local anesthesia medications.
The recall was initiated after internal testing identified that the flow rates of the two affected lots are outside the specified infusion time. This defect may result in the overly rapid infusion of medications.
The affected products were distributed in the United States through one importer/wholesale distributor in Missouri. Users should stop using the affected devices and contact B. Braun Medical, Inc. for instructions on return or replacement.
The recalled product
- Product
- B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Infusion Pump
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 (2)
- Catalog #CT-2000-100lots 3H0125F151 and 3H0225F151
- expiration 7/2018.
Distribution
Distributed in 1 state:
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