External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
This recall has been terminated (originally issued March 5, 2003).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- December 16, 2002
- Posted
- March 5, 2003
- Terminated
- October 31, 2003
- Recall Number
- Z-0606-03
- Quantity
- 8952
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The check valve in the patient line may stick in the closed position.
Distribution
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.
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.
Root Cause
Other
Action Taken
Integra notified their customers via recall letter and reply form on 12/16/2002 via FedEx.