—#181831

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.

FDA product code: OMP — Negative Pressure Wound Therapy Powered Suction Pump
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K143016
Affected lot / code info: Model Numbers: 48-4000, Lot numbers:201829015, 201923314, 201923316, 201923319, 20192347, 201923414, 201923410.

Why it was recalled

Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution and the country of Canada.

Timeline

Recall initiated: 2020-06-04
Terminated: 2025-08-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181831. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.