Z-0678-06

Shelhigh No-React Pulmonic Valve Conduit. 'Shelhigh No-React, Pulmonic Valve Conduit, NR4000-PA-C'...

Name: Z-0678-06 Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React, Pulmonic Valve Conduit, NR4000-PA-C'**...
Creator: Shelhigh, Inc.
Published: 2006-01-18
License: https://open.fda.gov/license/

Shelhigh, Inc. / initiated 2006-01-18 / Terminated

FDA source

Shelhigh, Inc. began a recall of Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React, Pulmonic Valve Conduit, NR4000-PA-C'** **'Shelhigh, Inc., 650 Liberty Ave., Union, NJ 07083... on 2006-01-18. The reason FDA records is "Unapproved Device-Distribution of an unapproved device into interstate commerce". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0678-06
Status: Terminated
Initiated: 2006-01-18
Posted: 2006-03-25
Terminated: 2007-05-23
Recalling firm: Shelhigh, Inc.
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'**.
Product code: MWH Pulmonic Valved Conduit
Reason for recall: Unapproved Device-Distribution of an unapproved device into interstate commerce.
FDA root cause: 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.
Product codes and lots: 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

Product code MWH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)