Prismaflex System, Catalog Number 107493, Indicated for continuous solute and/or fluid removal in patients with acute re

FDA device recall Z-1901-2011 · posted 2011-04-06 · Terminated

Recall details

Recalling firm

Gambro Renal Products, Incorporated

Reason for recall

Prismaflex touch screen may become unresponsive during Continuous Renal Replacement Therapy procedure.

Action taken

The firm, GAMBRO Renal Products, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated March 14, 2011 to all customers. The letter described the product, problem and actions to be taken. The customers were provided with response procedures to use if the frozen screen problem occurs while using the product. The customers were instructed to closely monitor the return line for potential air and/or clots in the circuit; review the instructions provided in the attached copy of Chapter 5: Troubleshooting, "Softkeys won't work." of the Prismaflex Operators Manual in conjunction with the attached Troubleshooting Checklist; be aware if performing Manual Termination with Blood Return, air detection is not provided, and complete and return the Customer Reply Form via fax to: Regulatory Affairs at 1-866-447-4471 or 303-222-6916, or by email to: GRPRegulatory.Affairs@us.gambro.com. If you have any questions or concerns, please contact for Clinical questions: ICON 800-554-1312 (available 24/7) or your local Gambro Representative; for Technical questions: Gambro Customer Support 800-525-2623, option 2 (Available 6:00am to 5:30pm MT, Monday thru Friday).

Root cause

Software change control

Status

Terminated

Product code

KDI

Quantity affected

1300 units

Distribution

Nationwide distribution.

Date initiated

2011-03-14

Date posted

2011-04-06

Date terminated

2011-09-01

Location

Lakewood, CO

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