Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7
FDA device recall Z-0844-2011 · posted 2011-01-10 · Terminated
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Hemodialysis Blood tubing Sets may develop kinking of the arterial line.
- Action taken
- Fresenius Medical issued recall notification dated 11/19/10, "URGENT RECALL FMCNA Combiset BVM Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-27957)", by certified mail with return receipt. Customers have been instructed to check their stock immediately to determine if they have any affected lots on hand. If customers have the affected lots, they have been instructed to discontinue use immediately and place the product in a secure segregated area for return to Fresenius Medical Care North America. Customers have been instructed to contact Fresenius Medical Care Customer Service Team Representative for instructions on how to return the recalled product.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FJK
- Quantity affected
- 10, 032 units (418 cases x 24 units)
- Distribution
- Distribution Nationwide and Canada
- Date initiated
- 2010-11-19
- Date posted
- 2011-01-10
- Date terminated
- 2012-11-03
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMBILINES HEMODIALYSIS BLOOD TUBING SET (K962081) | National Medical Care, Medical Products Div., Inc. | 1996-11-01 |