FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp: External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
- Recall number
- Z-0606-03
- Recalling firm
- Integra LifeSciences Corp
- Product
- External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
- Status
- Terminated
- Initiated
- 2002-12-16
- Posted
- 2003-03-05
- Terminated
- 2003-10-31
- Reason
- The check valve in the patient line may stick in the closed position.
- Root cause
- Other
- Action
- Integra notified their customers via recall letter and reply form on 12/16/2002 via FedEx.
- Quantity
- 8952
- 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, serial or model codes
- 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.
- 510(k) numbers
- ["K910853"]
- PMA numbers
- not on file
- Product code
- LID
- Firm FEI
- 1121308
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28