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U.S. Department of Health and Human Services

Class 2 Device Recall No React

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 Class 2 Device Recall No Reactsee related information
Date Initiated by FirmJanuary 18, 2006
Date PostedMarch 25, 2006
Recall Status1 Terminated 3 on May 23, 2007
Recall NumberZ-0678-06
Recall Event ID 34692
Product Classification Pulmonic Valved Conduit - Product Code MWH
ProductShelhigh 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 
FEI Number 1000081147
Recalling Firm/
Manufacturer		 Shelhigh, Inc.
650 Liberty Ave
Union NJ 07083-8130
For Additional Information ContactCurtis Truesdale
908-206-8706
Manufacturer Reason
for Recall		Unapproved Device-Distribution of an unapproved device into interstate commerce.
FDA Determined
Cause 2		Other
ActionThe 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 Commerce25 units
DistributionThe 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 CycleTPLC 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.
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