Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended fo
FDA device recall Z-2205-2012 · posted 2012-08-17 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- Reason for recall
- The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly
- Action taken
- CareFusion sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated July 20, 2012. The letter identified the product, problem, and actions to be taken by the customers. The potential risk identified in the letter was that when the pump module door keypad overlay has delaminated (loose, peeled away or separated from the door assembly) this could cause a potential for fluid ingress which could lead to a keypad malfunction causing termination of infusion with alarm. Termination of infusion could result in serious injury or death. Customers were informed that CareFusion will contact their facility with in 60 days of receiving the notification to schedule a visit to replace the door assembly of their affected pump module. Customers with recall related questions were instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports questions were instructed to contact Customer advocacy at (800) 854-7128, option 1, option 1, option 3 or e-mail at customer feedback @carefusion.com. Customers with technical questions were instructed to contact technical support at (888) 812-3229. Customers were instructed to promptly complete and return the enclosed Customer Response Card to expedite the corrective action process.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 43,862 units total (40,780 units in the US)
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.
- Date initiated
- 2012-06-15
- Date posted
- 2012-08-17
- Date terminated
- 2014-05-13
- 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 |