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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-0284-2007
Recall Event ID 36522
510(K)Number K921475  K875214  
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-06015
Code Information Product No. AP-06015. Lot Number: 11953, 12024, 12048, MF2122834, MF2122873, MF3013094,MF3023399, MF3033565, MF3033661, MF3043929,MF3044026, MF3044155, MF3054297, MF3054407, MF3064741, MF3074954, MF3085360, MF3106021,MF4016605, MF4020460, MF4031011, MF4031501, MF4041930, MF4062927,MF4063051, MF4073944, MF4094579, MF4094883, MF4095027, MF4116113,MF4126523, MF5017401, MF5049107, MF5049320, MF5059727, MF5060170,MF5060348, MF5060463, MF5081716, MF5082118, MF5082247, MF5113788,MF5113989, MF5124143, MF6014773, MF6025691, MF6036470, MF6036928,MF6047447, MF6057759, MF6058188, MF6068647, MF6079327, MS3110160,MS4073806.
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 890
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.
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