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U.S. Department of Health and Human Services

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-0275-2007
Recall Event ID 36522
510(K)Number K921475  K882230  
Product Classification Implantable Vascular Access System - Product Code LJT
Product Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter.

Latex-Free A Port, 10 Fr. Introducer Kit.
Ref Product No. AP-06520
Code Information Product No. AP-06520. Lot Number: MF1033516, MF2071649, MF2081937, MF2082002, MF2092208, MF2092278, MF2102373, MF2102462, MF2112595, MF2112688, MF2122960, MF3013060, MF3013065, MF3013198, MF3013279, MF3013308, MF3023367, MF3023427, MF3033567, MF3033642, MF3033732, MF3043847, MF3043910, MF3044134, MF3054228, MF3054338, MF3054447, MF3054465, MF3064645, MF3064763, MF3064833, MF3074927, MF3075118, MF3085281, MF3095491, MF3095574, MF3095611, MF3105931, MF3106006, MF3116245, MF3126277, MF3126278, MF3126318, MF3126396, MF3126417, MF3126450, MF4016582, MF4016635, MF4020551, MF4020553, MF4020806, MF4031020, MF4031582, MF4041771, MF4041936, MF4052333, MF4063058, MF4073792, MF4083964, MF4084041, MF4084292, MF4094582, MF4094706, MF4105124, MF4105261, MF4105486, MF4105803, MF4116118, MF5017414, MF5017549, MF5027701, MF5028033, MF5028158, MF5038602, MF5050176, MF5059737, MF5060355, MF5060468, MF5071341, MF5081670, MF5081671, MF5081762, MF5081870, MF5081902, MF5082122, MF5082249, MF5092841, MF5093006, MF5103341, MF5103508, MF5113683, MF5113875, MF5114153, MF5124319, MF5124528, MF6014777, MF6025871, MF6026069, MF6026200, MF6036711, MF6057765, MF6058113, MF6058190, MF6058298, MF6068660, MF6079304, MF6089737, MF6089985, MS3110155, MS3110156, MS3110157, MS3110158, MS4031056, MS4031058, MS4031059, MS4031065.
Recalling Firm/
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Paul Cornelison
Manufacturer Reason
for Recall
Catheter has separated from the infusion port body.
FDA Determined
Cause 2
Action The recall notification was sent out to their US customers on 9/29/2006.
Quantity in Commerce 4940
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 = THEREX CORP.