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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 16, 2002
Date Posted March 05, 2003
Recall Status1 Terminated 3 on October 31, 2003
Recall Number Z-0606-03
Recall Event ID 25255
510(K)Number K910853  
Product Classification unknown device name - Product Code LID
Product External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
Code Information 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.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp
105 Morgan Lane
Plainsboro NJ 08536
For Additional Information Contact Donna Wallace, RAC
609-936-2397
Manufacturer Reason
for Recall		 The check valve in the patient line may stick in the closed position.
FDA Determined
Cause 2		 Other
Action Integra notified their customers via recall letter and reply form on 12/16/2002 via FedEx.
Quantity in Commerce 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LID and Original Applicant = CORDIS CORP.
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