Class 2 Device Recall Peritoneal Lavage Kits

• Date Initiated by Firm: August 02, 2004
• Date Posted: August 25, 2004
• Recall Status: Terminated on August 22, 2005
• Recall Number: Z-1408-04
• Recall Event ID: 29819
• 510(K)Number: K811627
• Product Classification: Catheter, Peritoneal - Product Code GBW
• Product: Peritoneal Lavage Kits, Model number AK-09000
• Code Information: Lot numbers: RF3111181 exp. 7/06, RF4012217 exp. 9/06, RF4012309 exp. 8/06, RF4012781 exp. 8/06, RF4023104 exp. 8/06, RF4034175 exp. 9/06, RF4034346 exp. 9/06, RF4034553 exp. 9/06, RF4055424 exp. 11/06, RF4055592 exp. 12/06, RF4055908 exp. 11/06, and RF4066874 exp. 12/06.
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: Jody Cadd; 610-378-0131 Ext. 3318
• Manufacturer Reason for Recall: wrong introducer needle in some kits
• FDA Determined Cause: Other
• Action: The recalling firm issued a recall letter to their customers on 8/9/04. The letter instructed the accounts to return the product.
• Quantity in Commerce: 9100 units
• Distribution: The product was shipped to 45 distributors, 265 medical facilities nationwide, 7 firm sales representatives, 12 government accounts, and 9 foreign accounts.
• 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 = GBW and Original Applicant = ARROW INTL., INC.