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Class 2 Device Recall No React |
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Date Initiated by Firm |
January 18, 2006 |
Date Posted |
March 25, 2006 |
Recall Status1 |
Terminated 3 on May 23, 2007 |
Recall Number |
Z-0678-06 |
Recall Event ID |
34692 |
Product Classification |
Pulmonic Valved Conduit - Product Code MWH
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Product |
Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React¿, Pulmonic Valve Conduit, NR4000-PA-C'** **'Shelhigh, Inc., 650 Liberty Ave., Union, NJ 07083 ¿ USA'** **'Shelhigh Porcine Pulmonic Valve Conduit Prosthesis Model NR-4000 Series with 'No-React¿' treatment*, INSTRUCTIONS FOR USE'**. |
Code Information |
Model NR4000PA-C (size 6 mm), serial# PE19061, Lot# 030804-NR, Aug 2007 expiration Model NR4000PA-C (size 5 mm), serial# PE19089, Lot# 030924-NR, Sept 2007 expiration Model NR4000PA-C (size 6 mm), serial# PE20073, Lot# 040903-NR, Sept 2008 expiration Model NR4000PA-C (size 5 mm), serial# PE20678, Lot# 050222-NR, Feb 2009 expiration Model NR4000PA-C (size 6 mm), serial# PE20388, Lot# 050103-NR, Jan 2009 expiration Model NR4000PA-C (size 5 mm), serial# PE20677, Lot# 050222-NR, Feb 2009 expiration |
Recalling Firm/ Manufacturer |
Shelhigh, Inc. 650 Liberty Ave Union NJ 07083-8130
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For Additional Information Contact |
Curtis Truesdale 908-206-8706
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Manufacturer Reason for Recall |
Unapproved Device-Distribution of an unapproved device into interstate commerce.
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FDA Determined Cause 2 |
Other |
Action |
The firm retrieved the 6 devices from the consignees identified, following a telephone request on 1/18/2006. The firm does not consider this a recall. |
Quantity in Commerce |
25 units |
Distribution |
The devices were supplied directly to hospital and Shelhigh sales reps. There are two main accounts: Children's Hopsital of Boston, MA and Products for Surgery, Scottsdale, AZ (Shelhigh authorized salesman). The firm subsequently shipped a recalled unit, S/N PE20677 on 11/8/2005 to a European Distributor, Bioplan SRL, Parma, Italy. There are no Govt. accounts. |
Total Product Life Cycle |
TPLC Device Report
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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.
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