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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott

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  Class 2 Device Recall Abbott see related information
Date Initiated by Firm April 01, 2003
Create Date June 25, 2015
Recall Status1 Terminated 3 on October 09, 2003
Recall Number Z-0793-03
Recall Event ID 26046
510(K)Number K974778  
Product Classification Pump, Infusion - Product Code FRN
Product Gemstar¿ 6 Therapy I.V. Infusion Pump, List #: 13100-04; 2.9 Software Version
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Abbott Laboratories
755 Jarvis Drive
Morgan Hill CA 95037
Manufacturer Reason
for Recall		 Products contain software deficiencies which could allow over infusion thereby administering excess medication.
FDA Determined
Cause 2		 Other
Action On 4/1/03, the firm issued letters via Federal Express Overnight Delivery to all its direct consignees, informing them of the affected devices and providing instructions on the recall.
Quantity in Commerce 1310 units
Distribution Product received nationwide distribution to approx. 120 direct consignees. The firm identified 3 Govt. accounts: (1) Nthrn VA Comm. Hospital, 601 S. Carlin Spg. Rd., Arlington VA 22204, (2) Veterans Admin Med Ctr., 4100 W. 3rd St., Dayton OH 45428, (3) GW University Hospital, 901 23rd St. NW # 5306N, Washington DC 20037. The recall was appropriately extended to the user level; i.e., the hospital/medical centers, physicians and nurses who received the recalled product. There is no known Canadian distribution.
Total Product Life Cycle TPLC Device Report
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 = FRN and Original Applicant = ABBOTT LABORATORIES
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