Class 2 Device Recall Coronary control syringe.

• Date Initiated by Firm: September 14, 2004
• Date Posted: October 28, 2004
• Recall Status: Terminated on March 31, 2005
• Recall Number: Z-0049-05
• Recall Event ID: 30119
• 510(K)Number: K875196
• Product Classification: Syringe, Piston - Product Code FMF
• Product: 10 ml Inject 10 Palm Pad, sterile
• Code Information: Product Number CCXB010/A, Lot Number A337459.
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc; 1600 Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: 801-208-4405
• Manufacturer Reason for Recall: Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.
• FDA Determined Cause: Other
• Action: All consignees were notified by telephone and letter on 9/14/2004. A second letter, dated 11/24/04, was also sent to consignees.
• Quantity in Commerce: 25 syringes
• Distribution: Nationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands.
• Total Product Life Cycle: TPLC Device Report

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 = FMF