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U.S. Department of Health and Human Services

Class 3 Device Recall Arrow

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  Class 3 Device Recall Arrow see related information
Date Initiated by Firm November 04, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 12, 2004
Recall Number Z-0254-04
Recall Event ID 27681
510(K)Number K921475  K933316  K934802  K921475  K960200  
Product Classification Introducer, Catheter - Product Code DYB
Product Arrow A Port with Attachable Silicone Rubber Catheters/10 Fr.
Introducer Kit Implantable Vascular Access System (Product # AP-06520)
Product # AP-06520 kit contains 1 implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), straight non-coring needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
Code Information AP-06520 MF3074927  MF3075118  MF3085217  MF3085281  MF3095491  MF3095574  MF3095611 
Recalling Firm/
Manufacturer		 Arrow International Inc
2 Berry Dr
Mount Holly NJ 08060-5017
For Additional Information Contact Humberto Lozoya
609-267-0001
Manufacturer Reason
for Recall		 The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.
FDA Determined
Cause 2		 Other
Action The firm began notification of consignees via U.S. mail on 11/4/03. A notice of the recall was also posted on the firm''s website (search for 'recall').
Quantity in Commerce 913
Distribution Product was distributed internationally (France, Germany, Mexico, United Kingdom, Singapore, Brazil, Australia) and domestically. Domestic distribution was concentrated in the Midwest and Eastern portions of the US. Total direct accounts : Distributors/dealers, international - 7 Distributors/dealers, domestic - 5 Hospitals, domestic -36 Approximate percentage of each type of consignee: Distributors/dealers, international - 14.6% Distributors/dealers, domestic - 10.4% Hospitals, domestic - 75% Percentage of product sent to each type of consignee : Distributors/dealers, international - 70.8% Distributors/dealers, domestic - 7.9% Hospitals, domestic - 21.3% No VA or government contracts.
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 = DYB and Original Applicant = MSI, INC.
510(K)s with Product Code = DYB and Original Applicant = THEREX CORP.
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