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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-0277-2007
Recall Event ID 36522
510(K)Number K934802  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-06042.
Code Information Product No. AP-06042. Lot Numbers: 11916, MF2092169, MF2092256, MF3013079, MF3013159, MF3013315, MF3013320, MF3023358, MF3033614, MF3043940, MF3064659, MF3054234, MF3075086, MF3075140, MF3116147, MF3126395, MF4016579, MF4031049, MF4031484, MF4063059, MF4063266, MF4105260, MF4105483, MF4115980, MF4126889, MF4126890, MF5027945, MF5059894, MF5060175, MF5092679, MF5103210, MF5113791, MF5124527, MF6015496, MF6025735, MF6026194, MF6057764, MF6080022, MR3110192, MR3110194, MS2100122, MS4041843, MS4041844, MS4041845.
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 251
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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