2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hem...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2082-2013.
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
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2082-2013.
Recall terminated by FDA.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2082-2013.
Fresenius Medical Care Holdings, Inc. dba Renal Solutions
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Fresenius Medical Care Holdings, Inc. Dba Renal Solutions Recall FAQ
Fresenius Medical Care Holdings, Inc. Dba Renal Solutions is the subject of a medical devices safety report: 2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hem.... The notice was published on April 1, 2013 by the U.S. Food and Drug Administration (FDA). Approximately 132 units are potentially affected.