Class 2 Device Recall BD Alaris PCEA Administration Set

• Date Initiated by Firm: April 09, 2020
• Create Date: May 13, 2020
• Recall Status: Terminated on November 02, 2020
• Recall Number: Z-1967-2020
• Recall Event ID: 85525
• 510(K)Number: K811885
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-07 - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.
• Code Information: UDI: 10885403460234; Lot Numbers: 18125862 18125863 18125864 18125865 18126360 18126636 18126637 18126638 18126639 18126723 19015637 19015638 19015639 19015640 19015798 19015799 19015949 19017207 19025135 19025136 19025228 19025229 19046125 19046126
• Recalling Firm/ Manufacturer: BD SWITZERLAND SARL; Terre Bonne Park A4; Route De Crassier 17; Eysins Switzerland
• Manufacturer Reason for Recall: The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.
• FDA Determined Cause: Under Investigation by firm
• Action: URGENT MEDICAL DEVICE RECALL BD Alaris PCEA Administration Set and BD Alaris PCEA Administration Kit letters dated 4/9/20 were distributed to customers. Please Take the Following Actions: 1. Immediately review your inventory for the Catalog and Lot Numbers specified in this notification and discard all product subject to the recall. 2. Share this recall notification with any users of the product, within your facilities, to ensure they are also aware of this recall. 3. As a direct replacement will not be available for the foreseeable future, complete the attached Customer Response Form and return to the BD contact noted on the form. Please indicate whether you have any of the impacted product so that BD may acknowledge your receipt of this notification and process your credit. 4. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 Distributor Notice Please Take the Following Actions: 1. Immediately review your inventory for the Catalog and Lot Numbers specified in this notification and return all product subject to the recall to BD following the Packing Instructions enclosed. 2. Identify all your customers that purchased any affected product, as defined in this recall notification. Email an excel file listing of all customers to BDRC4@bd.com within 72 hours of receipt of this letter so that BD may notify customers directly. 3. Complete the attached Distributor Response Form and return to the BD contact noted on the form whether you have any of the impacted product so that BD may acknowledge your receipt of this notification and process your credit accordingly. 4. A copy of the customer communication is attached for your reference. Actions to be taken by BD: 1. BD will prov
• Quantity in Commerce: 110,350
• Distribution: Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.
• 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 = Y