Recalls / —
—#25470
Product
External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
- FDA product code
- LID
- 510(k) numbers
- K910853
- Affected lot / code info
- The External Drainage Sets lot numbers: 60300370, 60306608, 60306609, 60321387, 60300373, and 60376191. These lots of EDS may be included in the following set configurations: Catalog #: 910-109 Lot#: 0118080; 0118369; 0118572; 0118981; 0119845; 0117525. Catalog# 910-110A Lot #: 60300370; 60300373; 60306608; 60300370-1; 60321387; 60306608-1; 60306609; 60321387-1; 60306609-1; 60321387-2; 60376191; 60321387-3. Catalog# 910-112A Lot #: 0117569; 0117609; 0117834; 0117478; 0117833; 0117957; 0118062; 0118175; 0118420; 0118421; 0118573; 0118693. Catalog #910-118A Lot#: 0117570; 0117479; 0118023; 0118489; 0119150; 0119505. Catalog #910-120A Lot #: 0117536; 0117371; 0117453; 0117537; 0117902; 0117948; 0118047; 0118161; 0118422; 0118543; 0118616; 0118744; 0118808; 0118912; 0118955; 0119020; 0119081; 0119348; 0119500; 0119582. Catalog #910-123A Lot #: 0117805; 0118576; 0118845; 0118957.
Why it was recalled
The check valve in the patient line may stick in the closed position.
Root cause (FDA determination)
Other
Action the firm took
Integra notified their customers via recall letter and reply form on 12/16/2002 via FedEx.
Recalling firm
- Firm
- Integra LifeSciences Corp
- Address
- 105 Morgan Lane, Plainsboro, New Jersey 08536
Distribution
- 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.
Timeline
- Recall initiated
- 2002-12-16
- Posted by FDA
- 2003-03-05
- Terminated
- 2003-10-31
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #25470. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.