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U.S. Department of Health and Human Services

Class 2 Device Recall Peritoneal Lavage Kits

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  Class 2 Device Recall Peritoneal Lavage Kits see related information
Date Initiated by Firm August 02, 2004
Date Posted August 25, 2004
Recall Status1 Terminated 3 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/
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 2
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.