IV Infusion Pump Set Recalled for Backcheck Valve Malfunction Risk
B. Braun is recalling Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY (Model 362420) IV infusion sets due to backcheck valve malfunction that can cause medication to flow backward from secondary to primary IV containers.
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: This is an FDA Class II medical device recall for a malfunction that poses a risk of adverse drug reactions and medication loss. However, the source does not report any documented illnesses, injuries, or hospitalizations, placing this in the 'risk-of-harm where injury has not yet been reported' category per the rubric.
Plain-English summary
B. Braun Medical, Inc. is recalling the Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY (Model 362420) IV infusion pump sets due to a backcheck valve that may malfunction. A malfunctioning valve can result in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime the IV line.
Approximately 431,999 units are affected by this recall. The affected units were distributed worldwide, including throughout the United States and Canada. All lots distributed on or after August 1, 2023 are included in this recall.
A malfunctioning backcheck valve could result in loss of medication or blood from the IV containers, improper drug administration, and adverse drug reactions. Healthcare facilities should immediately cease use of affected infusion sets and contact B. Braun Medical, Inc. for guidance on replacement or return of the recalled product.
The recalled product
- Product
- Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362420
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- valve-malfunction
- medication-backflow
- drug-administration-error
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)
- UDI-DI 04046955592715
- All Lots Distributed After 01AUG2023.
Distribution
Distributed nationwide across the United States.
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