Class 2 Device Recall THORA/PARA TRAY, 5FR, NONVALVED

• Date Initiated by Firm: May 21, 2026
• Date Posted: July 02, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2655-2026
• Recall Event ID: 99096
• Product Classification: Thoracentesis tray - Product Code PXI
• Product: OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal spaces during an acute drainage / aspiration procedure.
• Code Information: OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 Lot Number: REKY3402 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 Lot Number: REKY3397 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 Lot Number: REKY3386
• FEI Number: 3006260740
• Recalling Firm/ Manufacturer: Bard Access Systems, Inc.; 605 N 5600 W; Salt Lake City UT 84116-3738
• For Additional Information Contact: Adam Daniels; 385-583-9999
• Manufacturer Reason for Recall: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 05/21/2026, the firm FedEx'd an "URGENT: Medical Device Recall" letter informing customers/distributed that BD has become aware that the FDA has placed Lidocaine manufactured by Huons Co., Ltd. on import alert #66-40 - Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs. BD is recalling products that contain the affected lidocaine ampules. Customers are instructed to: 1. Not to use the affected Lidocaine ampules. 2. Secure an alternative local Lidocaine drug prior to entering the procedural environment. 3. Upon opening the kit, remove and destroy the drug product from the BD convenience kits/procedure trays at the point of use, within a controlled and sterile environment to maintain the sterility of the remaining components within the kit. All other kit/tray components are safe to use. 4. If affected Lidocaine ampule was previously used without issue, no additional treatment or clinical follow up is required. 5. If affected Lidocaine ampule was previously used with issue, report the incident per institutional guidelines and take any necessary actions. Additional actions to take: 1. Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. 2. Post this notice on all inventory storage locations and any location where the product may be used. 3. Label affected kits/trays using the template provided in Appendix 2 to facilitate easy identification of products containing the affected ampules. The label can be printed using Avery template 5160. a. Apply the labels to the product without covering or obscuring any regulatory or traceability information. b. Apply to the top web of the kit/tray pressing firmly to ensure adhesion, while taking care not to damage or compromise the sterile barrier. For Questions - Contact North American Regional Complaint Center at 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompt
• Quantity in Commerce: 9,500
• Distribution: Worldwide U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.