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2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory fo...

FDA Device Recall #Z-2082-2013 — Class II — April 1, 2013

Recall Summary

Recall Number Z-2082-2013
Classification Class II — Moderate risk
Date Initiated April 1, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Fresenius Medical Care Holdings, Inc. dba Renal Solutions
Location Warrendale, PA
Product Type Devices
Quantity 132

Product Description

2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.

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

Distribution Pattern

USA Nationwide Distribution in the states of CA, MA, and NY.

Lot / Code Information

Serial numbers - TM-001065, TM-001283, TM-001284, TM-001325, TM-001411, TM-001426, TM-001465, TM-001476, TM-001529, TM-001967, TM-001968, TM-001975, TM-001985, TM-002015, TM-002016, TM-002017, TM-002018, TM-002021, TM-002022, TM-002095, TM-000015, TM-000028, TM-000031, TM-000041, TM-0048, TM-000050, TM-000051, TM-000053, TM-000055, TM-000059, TM-000064, TM-000065, TM-000068, TM-0069, TM-000213, TM-000215, TM-000218, TM-000219, TM-000070, TM-000072, TM-000074, TM-000075, TM-000078, TM-000081, TM-000082, TM-000083, TM-000085, TM-000086, TM-000087, TM-000088, TM-000089, TM-000092, TM-000040, TM-000077, TM-000098, TM-000101, TM-000102, TM-000103, TM-000104, TM-000105, TM-000106, TM-000107, TM-000108, TM-000109, TM-000112, TM-000113, TM-000114, TM-000115, TM-000116, TM-000122, TM-000123, TM-000124, TM-000125, TM-000126, TM-000128, TM-000145, TM-000002, TM-000003, TM-000004, TM-000005, TM-000006, TM-000007, TM-000008, TM-000009, TM-000010, TM-000012, TM-000013, TM-000014, TM-000017, TM-000018, TM-000019, TM-000020, TM-000023, TM-000024, TM-000025, TM-000033, TM-000036, TM-A595, TM-A610, TM-A627, TM-000220, TM-000227, TM-007364, TM-007371, TM-006848, TM-006860, TM-006875, TM-006879, TM-006880, TM-006881, TM-006882, TM-006883, TM-006884, TM-006885, TM-006886, TM-006887, TM-006890, TM-006891, TM-006892, TM-006893, TM-006897, TM-006898, TM-006911, TM-006912, TM-006913, TM-006914, TM-006915, TM-006916, TM-006917, TM-006918, TM-006919, and TM-006920.

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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