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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 Kitssee related information
Date Initiated by FirmAugust 02, 2004
Date PostedAugust 25, 2004
Recall Status1 Terminated 3 on August 22, 2005
Recall NumberZ-1409-04
Recall Event ID 29819
Product Classification Catheter, Peritoneal - Product Code GBW
ProductPeritoneal Lavage Kits, Model number AK-09001
Code Information Lot numbers: RF3111152 exp. 5/08, RF3121739 exp. 8/06, RF4012282 exp. 7/08, RF4012530 exp. 7/08, RF4034376 exp. 10/06, RF4034554 exp. 11/08, RF4045029 exp. 11/08, and RF4066325 exp. 1/09.
FEI Number 3015859709
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information ContactJody Cadd
610-378-0131 Ext. 3318
Manufacturer Reason
for Recall		wrong introducer needle in some kits
FDA Determined
Cause 2		Other
ActionThe recalling firm issued a recall letter to their customers on 8/9/04. The letter instructed the accounts to return the product.
Quantity in Commerce9100 units
DistributionThe product was shipped to 45 distributors, 265 medical facilities nationwide, 7 firm sales representatives, 12 government accounts, and 9 foreign accounts.
Total Product Life CycleTPLC 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.
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