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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Plumset

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  Class 2 Device Recall Abbott Plumset see related information
Date Initiated by Firm May 13, 2003
Date Posted June 17, 2003
Recall Status1 Terminated 3 on November 20, 2003
Recall Number Z-0936-03
Recall Event ID 26349
510(K)Number K791930  K832755  K865060  K941214  
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
Code Information List number 19020-04-12, lot 941845H
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		 The I.V. administration set incorrectly lists the priming volume from the cassette inlet to distal male adapter as 13.5 mL instead of 11.3 mL
FDA Determined
Cause 2		 Other
Action Recall letter dated 5/12/03 sent to the account on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lot to Abbott for credit.
Quantity in Commerce 4,656 units
Distribution Miami, FL
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 = ABBOTT MFG., INC.
510(K)s with Product Code = FPA and Original Applicant = OMNI-GLOW, INC.
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