Alaris Pump Module model 8100
FDA device recall Z-2700-2017 · posted 2017-06-19 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.
- Action taken
- An Urgent Medical Device Recall letter will be sent on 6/12/17 to customers to inform them that BD is issuing this letter to inform you of a potential risk associated with the Alaris Pump module. Firm identified a specific scenario that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. This scenario is reproducible under the following situations: a) the user does not close the roller clamp on the IV administration set before the pump door is opened as recommended, and b) opening the pump door using an atypical technique with the door latch with the centered sear design. The letter instructs customers If their device has a centered-sear that was manufactured between June 2002 to June 2004, clearly mark and sequester (e.g. Biomed department) the Alaris Pump module that exhibited the issue. Notify CareFusion Customer Advocacy at 888-812-3266 or customerfeedback@carefusion.com to coordinate an onsite remediation or send the devices to the BD Service Depot.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 35,940 units
- Distribution
- US and Canada
- Date initiated
- 2017-06-12
- Date posted
- 2017-06-19
- Date terminated
- 2019-01-28
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS (K950419) | Imed Corp. | 1995-06-21 |