2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 20
FDA device recall Z-2082-2013 · posted 2013-08-26 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc. dba Renal Solutions
- Reason for recall
- Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements. This may lead to a slight over or under delivery of Venofer(R) that does not pose an acceptable risk to the patient. Please note that this recall
- Action taken
- Renal Solutions sent an Urgent Notification letter dated April 1, 2013 via certified mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to cease further use of the device. The letter informed customers that a Fresenius Medical Care Technical Service/Customer Service representative will contact customers to arrange for removal of the device. For questions contact Fresenius Medical Care Customer Service at 800-227-2572.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KDI
- Quantity affected
- 132
- Distribution
- USA Nationwide Distribution in the states of CA, MA, and NY.
- Date initiated
- 2013-04-01
- Date posted
- 2013-08-26
- Date terminated
- 2015-03-02
- Location
- Warrendale, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VENOFER PUMP (K121497) | Renal Solutions, Inc. | 2012-08-17 |