Devices

Device Recall No React

Model / Serial
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 Classification
Cardiovascular Devices
Device Class
HDE
Implanted device?
Yes
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 Description
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'**.
Manufacturer
Shelhigh, Inc.
1 Event
- Recall of Device Recall No React

Manufacturer

Shelhigh, Inc.

Manufacturer Address
Shelhigh, Inc., 650 Liberty Ave, Union NJ 07083-8130
Source
USFDA

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