Class 2 Device Recall Alaris Extension Sets with Microbore Tubing

• Date Initiated by Firm: November 06, 2017
• Create Date: June 07, 2018
• Recall Status: Terminated on December 07, 2020
• Recall Number: Z-2111-2018
• Recall Event ID: 80093
• 510(K)Number: K790108 K790582
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Alaris Extension Sets with microbore tubing Model 20022 and 30914 Is used to administer fluid and medications from a syringe to the patient through a needle or catheter inserted into the patient's artery or vein. These model codes are extension sets that can be used with IV administration sets. The set s components are commonly found on intravascular administration sets and extension sets. It includes a microbore tubing, a slide clamp, male and female luer.
• Code Information: Model 20022 Lot Numbers 16087775, Model 20022 Lot Numbers 16127995 and Model 30914 Lot Numbers 16127518 and 17097167
• Recalling Firm/ Manufacturer: CareFusion 303, Inc.; 10020 Pacific Mesa Blvd; San Diego CA 92121-4386
• For Additional Information Contact: BD Support Center; 888-562-6018
• Manufacturer Reason for Recall: Reports of incorrect priming volume due to manufacturing with incorrect tubing.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, BD, sent an "URGENT: Medical Device Recall Notification" letter dated November 2017 to all their customers. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately Discontinue use of the Alaris Extension Sets model 20022 lot numbers 16087775 and 16127995, and model number 30914 lot number 16127518. Contact BD for a replacement lot.; return the product for replacement using the following instructions; and immediately complete and return to BD the enclosed, pre-addressed and postage paid, Recall Response Card to: BD Support Center,10020 Pacific Mesa Blvd, San Diego CA 92121, by FAX: 1-858-617-4851 or by EMAIL: SupportCenter@bd.com. Note on the card your distributors name and quantities that will be returned. " Once BD receives the Recall Response Card, the BD Support Center will provide instructions for return of the affected lot numbers and replacement of the affected lots. " " All recalled product should be returned directly to the distributor from whom it was purchased. Customers will receive their return goods processed through their distributor if the products were purchased through a distributor. " " Your distributor has already been notified of this recall. If you have any questions, please contact your distributor directly, or call the BD Support Center at the number listed below." A second letter was sent on May 2018 adding an additional lot # for Alaris Extension Set with microbore tubing Model number 30914 lot number 17097167 Recall Related Questions BD Support Center Phone: 1-888-562-6018 Hours: 7am to 4pm PST, Monday -Friday Email: SupportCenter@carefusion.com
• Quantity in Commerce: 25,400 units
• Distribution: US Distribution to states of: CA, IL, IN, KS, NE, NJ, TX, UT, VA and WA
• 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