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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-0280-2007
Recall Event ID 36522
510(K)Number K933316  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. 10 Fr. Introducer Kit
Ref Product No. AP-06022
Code Information Product No. AP-06022. Lot Numbers: 12025, 12026, MF2082053, MF2092149, MF2102348, MF2112612, MF2112798, MF2122887, MF3013239, MF3023441, MF3033609, MF3033767, MF3043953, MF3054471, MF3054551, MF3064671, MF3064720, MF3074950, MF3075080, MF3085227, MF3085410, MF3106022, MF3126356, MF3116146, MF4020300, MF4020624, MF4031189, MF4041636, MF4041931, MF4052351, MF4063054, MF4063107, MF4063265, MF4073781, MF4073838, MF4105285, MF4105479, MF4105680, MF4126531, MF4126772, MF4126885, MF5017407, MF5028155, MF5038764, MF5050041, MF5059731, MF5059893, MF5060649, MF5081721, MF5082121, MF5092678. MF5103209, MF5103504, MF5113992, MF5114145, MF5124303, MF6015495, MF6036710, MF6047367, MF6047368, MF6057762, MF6058411, MF6068650, MS3110150, MS4041840.
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 1924
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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