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Class 2 Device Recall Arrow

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  Class 2 Device Recall Arrow see related information
Date Initiated by Firm September 29, 2006
Date Posted December 19, 2006
Recall Status1 Terminated 3 on June 04, 2007
Recall Number Z-0281-2007
Recall Event ID 36522
510(K)Number K933350  K790882  
Product Classification Implantable Vascular Access System - Product Code LJT
Product Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.

Latex-Free Low Profile Port. 9 Fr. Introducer Kit
Ref Product No. AP-06020
Code Information Product No. AP-06020. Lot Numbers: MF1075363, MF2071759, MF2071795, MF2081849, MF2081900, MF2122871, MF2122962, MF3013303, MF3023498, MF3033750, MF3054449, MF3054482, MF3085186, MF3085246, MF3085395, MF3095548, MF3116233, MF3116244, MF4020723, MF4020901, MF4031014, MF4031015, MF4031466, MF4052331, MF4062929, MF4063264, MF4084283, MF4094580, MF4094705, MF4105328, MF4105577, MF4115963, MF4126528, MF4126656, MF4126883, MF4126884, MF5017406, MF5027697, MF5028032, MF5028154, MF5038599, MF5050172, MF5059730, MF5059892, MF5060353, MF5060465, MF5070948, MF5081719, MF5081720, MF5124397, MF5082119, MF5092548, MF5103503, MF5103681, MF5113874, MF5124524, MF6014999, MF6047362, MF6047363, MF6047523, MF6057740, MF6057761, MF6068649, MF6068928, MF6079295, MF6079297.
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Paul Cornelison
610-378-0131
Manufacturer Reason
for Recall		 Catheter has separated from the infusion port body.
FDA Determined
Cause 2		 Other
Action The recall notification was sent out to their US customers on 9/29/2006.
Quantity in Commerce 514
Distribution Nationwide. The firm is NOT recalling from international 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 = LJT and Original Applicant = INTROSTAT
510(K)s with Product Code = LJT and Original Applicant = THEREX CORP.
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