Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9
FDA Recall Z-0843-2011 · Posted 2011-01-10
Recalling FirmFresenius Medical Care Holdings, Inc.
Recall StatusTerminated
Product CodeFJK
Date Initiated2010-11-19
Date Terminated2012-11-03
Product Quantity190,080 units (7920 cases x 24 units)
Reason for Recall
Hemodialysis Blood tubing Sets may develop kinking of the arterial line.
Firm Action
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
Distribution Pattern
Distribution Nationwide and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.