BD Alaris Pump Infusion Sets Recalled for Performance Data Discrepancies
BD Switzerland is recalling BD Alaris Pump Infusion Sets due to discrepancies in performance data that may lead to inappropriate pump performance.
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 where performance discrepancies may lead to inappropriate pump performance, representing a risk of harm where injury has not yet been reported.
Plain-English summary
BD Switzerland SARL is recalling specific lots of BD Alaris Pump Infusion Sets. The recall was initiated due to discrepancies in specific attributes within the performance data for these infusion sets.
These discrepancies may lead to inappropriate pump performance. The affected products include various models of BD Alaris Pump Infusion Sets and Blood Sets, distributed nationwide in the United States and in numerous international markets.
Healthcare facilities and consumers should stop using the affected infusion sets and contact BD Switzerland for further instructions or replacement.
The recalled product
- Product
- BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sites 10015861A 10885403232626 50885403232624 BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, PE Lined Tubing, Back Ch
- Manufacturer
- BD SWITZERLAND SARL
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 94,230,757
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 (20)
- 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set
- 15 Micron Filter
- Back Check Valve
- SmartSite Bag Access Non-Vented
- PE Lined Tubing
- 2 Back Check Valves
- 180 Micron Filter
- Bonded Texium
- Closed Male Luer with Priming Cap
- 0.2 Micron Filter
- Bonded Texium Closed Male Luer with Priming Cap
- 1.2 Micron Filter
- Smallbore Tubing
- SmartSite Port (Burette)
- Manifold
- 3-Way Stopcock
- 2 Ganged 4-Way Stopcocks
- 3 Ganged 4-Way Stopcocks
- Vented Syringe Adapter
- Bonded Texium Closed Male
Distribution
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