—#52173

Product

EnDura No-React Dural Substitute 12 cm Diameter

FDA product code: DTZ — Oxygenator, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Product code: ENR21212 : all lots

Why it was recalled

Integra LifeSciences Corporation d/b/a Integra NeuroSciences, the distributor of EnDura No-React Dural Substitute, manufactured by Shelhigh, Inc., Union, NJ, is recalling this product based on an FDA Public Health Notification and FDA requested recall letter to Shelhigh citing sterility and other manufacturing concerns regarding this product manufactured by Shelhigh. Integra is a distributor of t

Root cause (FDA determination)

Other

Action the firm took

On May 4, 2007, an Urgent Recall Notice and accompanying recall acknowledgement form was sent to all customers that had purchased or been supplied EnDura No-React Dural Substitute product since sale of the product was initiated in 2003. Recall Coordinators at each facility are asked to review inventory for EnDura products and to call Integra Customer Service for an authorization number for return of product.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Nationwide Distribution to hospitals and medical centers

Timeline

Recall initiated: 2007-05-04
Posted by FDA: 2007-05-24
Terminated: 2008-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52173. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.