Class 3 Device Recall Healon GV

• Date Initiated by Firm: December 11, 2003
• Date Posted: January 14, 2004
• Recall Status: Terminated on April 08, 2004
• Recall Number: Z-0346-04
• Recall Event ID: 28002
• Product Classification: Cannula, Ophthalmic - Product Code HMX
• Product: Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only, Manufactured by Pharmacia AB Sweden for Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation, Kalamazoo, MI 49001 USA, MADE IN SWEDEN.
• Code Information: Lots: #5047293 and #5048892
• FEI Number: 3004293943
• Recalling Firm/ Manufacturer: Cardinal Health; 6540 Port Rd; Groveport OH 43125-9103
• For Additional Information Contact: Serrah Namini; 949-580-1555 Ext. 4401
• Manufacturer Reason for Recall: The product was not held at the labeled storage temperatures, which could affect the product potency and/or physical properties, were distributed.
• FDA Determined Cause: Other
• Action: The firm contacted their consignees on 12/11/2003 by telephone and letter.
• Quantity in Commerce: 110 vials
• Distribution: The product was distributed to customers in OH and PA.
• 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.