—#120010

Product

2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.

FDA product code: ONW — Hemodialysis System For Home Use
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K070049
Affected lot / code info: All lot codes

Why it was recalled

Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss

Root cause (FDA determination)

Labeling design

Action the firm took

Fresenius issued a Field Notification Letter dated 8/29/13 to Patient Clinics/ associated at home patients and provides additional detail instructions to ensure the connection to the transducer protector bloodline female luer interface is secure. This field advisory notice sent by Certified Mail, Return Receipt Requested. Accounts requested to return both the receipt and the completed reply form (enclosed) to confirm receipt of the notice. If you have any questions regarding this field advisory, please contact FMCNA Customer Service Team at 1-800-323-5188. Customer Service will be available Monday-Friday 7am-6pm CST.

Recalling firm

Firm: Fresenius Medical Care Holdings, Inc.
Address: 920 Winter St, Waltham, Massachusetts 02451-1521

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the country of Canada.

Timeline

Recall initiated: 2013-08-29
Posted by FDA: 2013-11-08
Terminated: 2021-02-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #120010. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.