Class 2 Device Recall PowerLoc MAX Power Injectable Infusion Set

• Date Initiated by Firm: June 19, 2020
• Date Posted: July 20, 2020
• Recall Status: Terminated on July 29, 2022
• Recall Number: Z-2660-2020
• Recall Event ID: 85853
• 510(K)Number: K153440
• Product Classification: Non-coring (Huber) needle - Product Code PTI
• Product: PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224)
• Code Information: Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 00801741119224). Lot Numbers: REDT4257 REDV3617 REDY1815 REDY2789 REDZ0385 REEN2192 REEN2782 REDW2682 REDX1471 REDX3857 REDY0765 REDY1593 REDY2943 REDZ0676 REDZ1903 REDZ3077 REEN1222 REEN3292 REEP0666 REEP4137 REER0612 REDW1021 REDX1360 REDX4728 REDY1816 REDY2935 REDY3765 REDZ1825 REDZ3146 REEN1935 REEP0773 REEP3544 REEP4066 REER0579 REER1103 REDV2172 REDV3683 REDW0467 REDW0521 REDW1023 REDW1157 REDX1361 REDX1490 REDY0815 REDY1594 REDY2790 REDY3544 REDZ0110 REDZ0386 REDZ0677 REDZ1904 REDZ3078 REEN1072 REEN2186 REEN3075 REEN3310 REEP0663 REEP1401 REEP4138 REEQ0611 REEQ1246 REEQ2436 REEQ3589 REER0576 REER1046 REER2161 Additional lot added 10/16/20: REEU0314
• FEI Number: 2243072
• Recalling Firm/ Manufacturer: Becton Dickinson & Company; 1 Becton Dr; Franklin Lakes NJ 07417-1815
• For Additional Information Contact: Customer/Technical Support; 800-290-1689
• Manufacturer Reason for Recall: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.
• FDA Determined Cause: Process control
• Action: URGENT MEDICAL DEVICE RECALL notification letters dated 6/19/20 were sent to customers. PLEASE TAKE THE FOLLOWING ACTIONS: 1. Immediately review your inventory for the specific catalog and lot numbers referenced in Attachment A. Discontinue use of those devices and destroy all product subject to this recall following your institutions process for destruction. MDS-20-1979 Page 2 of 28 BD Medical 1 Becton Drive Franklin Lakes, NJ 07417 USA bd.com 2. Share this notification with all users of the product within your facility network to ensure they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your credit accordingly for the discarded material. a. Customers who purchased product directly from BD will receive credit. b. Customers who did not purchase product directly from BD will need to contact their distributor to obtain credit. 4. Report any adverse health consequences experienced with the use of this product to BD at product.complaints@bd.com. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1800FDA1088 (18003321088) Mail: MedWatch, HF2, FDA, 5600 Fishers Lane, Rockville, MD 208529787 Customer/Technical Support Phone: 8002901689 Monday  Friday between 8:00 am to 5:00 pm MDT SLCBASD.FieldAction@bd.com An Urgent Medical Device Recall notification letter dated 8/25/20 was sent to customers informing them of two additional lots of affected product. An URGENT MEDICAL DEVICE RECALL UPDATE dated 10/7/20 was sent to customers informing them of two additional lots of affected product.
• Quantity in Commerce: 5,296,132 total
• Distribution: Worldwide Distribution
• 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 = PTI