Class 2 Device Recall Abbott Plumset

• Date Initiated by Firm: May 13, 2003
• Date Posted: June 17, 2003
• Recall Status: Terminated 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: 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; 510(K)s with Product Code = FPA; 510(K)s with Product Code = FPA