Class 3 Device Recall DURACUF

• Date Initiated by Firm: October 24, 2000
• Date Posted: September 17, 2003
• Recall Status: Terminated on June 06, 2008
• Recall Number: Z-1236-03
• Recall Event ID: 26245
• 510(K)Number: K974080
• Product: Critikon brand Adult, DURA-CUF, product code 2790, used as an arm cuff in association with a blood pressure monitor.
• Code Information: lot number 2290
• Recalling Firm/ Manufacturer: GE Medical Systems Information Technologies; 4502 Woodland Corporate Blvd.; Tampa FL 33614
• For Additional Information Contact: Thomas English; 813-887-2525
• Manufacturer Reason for Recall: Incorrrect male connector attached to tubing preventing the correct connection of blood pressure cuff.
• FDA Determined Cause: Other
• Action: A Recall notification letter was mailed to all direct accounts on 10/24/2000 followed by a telephone call to each direct account. Distributors were not requested to subrecall because Critikon already knew the hospital accounts that had recieved product and they were notified via the 10/24/00 letter and phone call. Accounts were told to return product to Critikon for replacement.
• Quantity in Commerce: 235
• Distribution: Product was distributed to the firm''s related warehouse in Texas and then on to 20 distributors and 8 hospitals in the United States and also one international distributor in Japan.

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code =