Recalls / —
—#95765
Product
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9
- FDA product code
- FJK — Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K962081
- Affected lot / code info
- Lots 10HR01065, 10HR01083, 10HR01197, 10HR01259, 10JR01019, 10JR01031, 10JR01040, 10JR01058, 10JR01067, 10JR01077, 10JR01239, 10LR01041, 10LR01041, 10LR01053, 10LR01061, 10LR01070, 10LR01102, 10LR01111, 10LR01123, 10LR01269, 10LR01282, 10LR01283, 10LR01284, 10LR01285, 10NR01020, 10NR01031, 10NR01041, 10NR01050, 10NR01146, 10NR01157, 10NR01169, 10NR01180
Why it was recalled
Hemodialysis Blood tubing Sets may develop kinking of the arterial line.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Fresenius Medical Care Holdings, Inc.
- Address
- 920 Winter St, Waltham, Massachusetts 02451-1521
Distribution
- Distribution pattern
- Distribution Nationwide and Canada
Timeline
- Recall initiated
- 2010-11-19
- Posted by FDA
- 2011-01-10
- Terminated
- 2012-11-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #95765. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.