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Class 2 Device Recall Arrow

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 Class 2 Device Recall Arrowsee related information
Date Initiated by FirmSeptember 29, 2006
Date PostedDecember 19, 2006
Recall Status1 Terminated 3 on June 04, 2007
Recall NumberZ-0282-2007
Recall Event ID 36522
510(K)NumberK922434 K926011 
Product Classification Implantable Vascular Access System - Product Code LJT
ProductImplantable Vascular Access system --Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 9 Fr. Introducer Kit. Ref. Product No. AP-06018.
Code Information Product No. AP-06018. Lot Numbers: MF2071557, MF2081915, MF2112752, MF3013138, MF3013309, MF3043927, MF3054236, MF3054472, MF3054594, MF3074941, MF3075061, MF3085480, MF3095763, MF3116074, MF3116187, MF4016702, MF4016725, MF4020805, MF4031013, MF4031188, MF4031373, MF4052203, MF4063052, MF4073779, MF4073837, MF4094885, MF4105259, MF4105799, MF4126881, MF5017404, MF5028031, MF5038301, MF5038425, MF5038760, MF5049322, MF5059729, MF5059889, MF5060171, MF5081718, MF5103002, MF5103502, MF5113789, MF5113991, MF6014861, MF6014998, MF6036561, MF6036618, MF6058293, MF6058347, MF6068925.
FEI Number 3015859709
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information ContactPaul Cornelison
610-378-0131
Manufacturer Reason
for Recall		Catheter has separated from the infusion port body.
FDA Determined
Cause 2		Other
ActionThe recall notification was sent out to their US customers on 9/29/2006.
Quantity in Commerce452
DistributionNationwide. The firm is NOT recalling from international 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.
510(K) Database510(K)s with Product Code = LJT
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