Class 2 Device Recall NPWT 300cc Canister with Gel Occlusion Detection

• Date Initiated by Firm: June 04, 2020
• Create Date: July 10, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2544-2020
• Recall Event ID: 85803
• 510(K)Number: K143016
• Product Classification: negative pressure wound therapy Powered suction pump - Product Code OMP
• Product: Cardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.
• Code Information: Model Numbers: 48-4000, Lot numbers:201829015, 201923314, 201923316, 201923319, 20192347, 201923414, 201923410.
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 3651 Birchwood Dr; Waukegan IL 60085-8337
• For Additional Information Contact: 888-444-5440
• Manufacturer Reason for Recall: Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Cardinal Health issued a letter titled, "Urgent Medical Device Recall", to customers on 06/04/2020. The letter advises customers of a voluntarily recalling associated with lots of Cardinal Health NPWT 300cc Canister with gel and Cardinal Health NPWT 300cc Canister with gel Occlusion Detection. The recall is being conducted due to Canisters potentially containing an oversized O-ring. The canisters with the oversized O-ring cannot be installed into the mating connector on the device causing the device to be unusable. According to the letter, customers should check all storage and usage locations to confirm whether they have any units of the affected product, quarantine all on-hand product and return the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648 or email at GMB-FieldCorrectiveAction@cardinalhealth.com. The returned form should indicate the product code, lot and quantity of product quarantined or discarded. Response is needed whether or not customers have affected product. Customers should notify any customers to whom they may have distributed, or forward the product affected by the recall and should include a copy of the recall notification letter. The firm customer service is available Monday to Friday between 8:00am - 5:00pm Eastern Time. The firm contact information is listed as: Hospital: 800-964-5227, Federal Government: 800-444-1166, Distributor: 800-635-6021, All other Customers: 888-444-5440.
• Quantity in Commerce: 1960
• Distribution: Worldwide distribution - US Nationwide distribution and the country of Canada.
• 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.

• 510(K) Database: 510(K)s with Product Code = OMP and Original Applicant = CARDINAL HEALTH