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Terminated

External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.

FDA Recall Z-0606-03 · Posted 2003-03-05

Recalling FirmIntegra LifeSciences Corp
Recall StatusTerminated
Product CodeLID
Date Initiated2002-12-16
Date Terminated2003-10-31
Product Quantity8952

Reason for Recall

The check valve in the patient line may stick in the closed position.

Firm Action

Integra notified their customers via recall letter and reply form on 12/16/2002 via FedEx.

Root Cause

Other

Distribution Pattern

The affected products have been distributed to hospitals, distributors, and Integra Sales Representatives. There are 202 direct hospital customers, 5 foreign distributors, and 1 wholesaler. Government distribution include the National Institute of Health in Bethesda, MD and 9 Veterans Administration Hospitals. International distributions to the following countries: United Arab Emirates, Argentina, Australia, Austria, Belgium, Brazil, Canada, Switzerland, Germany, Spain, France, Gabron, United Kingdom, Greece, Hong Kong, Ireland, Italy, Malaysia, Netherlands, Poland, Saudi Arabia, Sweden, Turkey, South Africa, and Mexico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K910853GRADUATED CYLINDER OF EXTERNAL DRAINAGE SETCordis Corp. · 1991-04-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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