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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-0278-2007
Recall Event ID 36522
510(K)Number K942412  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 -06040
Code Information Product No. AP-06040. Lot Numbers: MF2082014, MF2092092, MF2102287, MF2122972, MF3023424, MF3033561, MF3033608, MF3054587, MF3074949, MF3075147, MF3085288, MF3085340, MF3095656, MF3095740, MF3105983, MF3126394, MF4016539, MF4031048, MF4031211, MF4031352, MF4041932, MF4062931, MF4063056, MF4083962, MF4084405, MF4126532, MF5017410, MF5038601, MF5050044, MF5059734, MF5081723, MF5124399, MF6015389, MF6025738, MF6026066, MF6047369, MF6047370, MF6025851, MF6057763.
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 288
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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