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U.S. Department of Health and Human Services

Class 3 Device Recall LifeShield Microdrip Soluset

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  Class 3 Device Recall LifeShield Microdrip Soluset see related information
Date Initiated by Firm May 13, 2003
Date Posted June 05, 2003
Recall Status1 Terminated 3 on November 20, 2003
Recall Number Z-0914-03
Recall Event ID 26343
510(K)Number K991932  K915571  K791930  
Product Classification Set, Administration, Intravascular - Product Code FPA
Product LifeShield Latex-Free 150 mL Burette Set, Nonvented, 117 Inch with Prepierced Injection Site, Backcheck Valve, 2 CLAVE Ports and Removable 4-Way High Flow Stopcock Microdrip Soluset; Product 19292; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
Code Information Product number 19292-04-01, lots 961815H and 921675H
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information Contact Abbott Customer Service
800-222-6883
Manufacturer Reason
for Recall		 IV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.
FDA Determined
Cause 2		 Other
Action Recall letter dated 5/12/03 sent to the accounts on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lots to Abbott for credit.
Quantity in Commerce 7,160 units
Distribution Nationwide. California, Colorado, Connecticut, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Montana, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington and Wisconsin.
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 = FPA and Original Applicant = ABBOTT LABORATORIES
510(K)s with Product Code = FPA and Original Applicant = ICU MEDICAL, INC.
510(K)s with Product Code = FPA and Original Applicant = THE KIPP GROUP
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