Class 2 Device Recall JOBST Compri2 & JOBST Compri2 Lite

• Date Initiated by Firm: February 01, 2022
• Create Date: June 03, 2022
• Recall Status: Terminated on August 09, 2023
• Recall Number: Z-1228-2022
• Recall Event ID: 89530
• Product Classification: Bandage, elastic - Product Code FQM
• Product: (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.; ; (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.
• Code Information: Lot #127384, Exp. 2024-02-10 UDI for JOBST Compri2 - (01)04042809506648(20)01(17)240210(10)127384; UDI for JOBST Compri2 lite - (01)04042809506631
• Recalling Firm/ Manufacturer: BSN Medical Inc; 5825 Carnegie Blvd; Charlotte NC 28209-4633
• For Additional Information Contact: Amy Bellcourt; 610-499-3348
• Manufacturer Reason for Recall: The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm issued letters dated 1/31/2022 on 2/1/2022 via email and made telephone calls. The letter informed the consignee of the issue, provided photographs of the labeling, and requested the consignee check their inventory to determine if they have the affected lot number of JOBST Compri2 and JOBST Compri2 Lite in their inventory. If they do, they are requested to quarantine the product and share this information with additional departments as needed. Enclosed with the letter was a Response Form for completion, as well as prepared labels for return of the affected product. The response form and the affected product were to be returned to the firm. The letter also informs the consignee to ensure all users and individuals in their organization be informed of the recall. If the consignee supplies products to third parties, they are requested to forward a copy of the information or inform the recalling firm's contact person. Based on feedback from the Division on their recall letter, the letter was updated to extend the recall to all direct account locations. The updated letters dated 2/3/2022 were issued beginning 2/4/2022 via email and phone calls were again made. The letters were similar to the previous letter dated 1/31/2022 except there was an instruction added that said if the product was further distributed to customers of the consignee, they are to provide a list of those customers to BSN Medical so that BSN can follow-up with them regarding the recall. In the event the consignee does not want to provide a copy of their customer list, they are requested to supply data to support their firm's compliance with the customer recall notification.
• Quantity in Commerce: 1,677
• Distribution: US Nationwide distribution in the states of AZ, FL, CA, IL, KS, MA, MN, MO, NC, NH, OH, PA, TX, VA, and WA. There was no foreign/government/military 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.