Z-2543-2020Class II

Cardinal Health NPWT Canister with Gel 300cc, Prescription Only -

Name: Z-2543-2020 Cardinal Health NPWT Canister with Gel 300cc, Prescription Only -
Creator: Cardinal Health 200, LLC
Published: 2020-06-04
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-06-04 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic... on 2020-06-04. FDA classified it as Class II and gives the reason as "Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2543-2020
Classification: Class II
Status: Terminated
Initiated: 2020-06-04
Posted: 2020-07-10
Terminated: 2025-08-05
Recalling firm: Medtronic, Inc.
Product: Cardinal Health NPWT Canister with Gel 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.
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
Reason for recall: Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
Root cause tag: manufacturing process
FDA root 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 [email protected]. 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: 3000
Distribution: Worldwide distribution - US Nationwide distribution and the country of Canada.
Product codes and lots: Model Numbers: 47-4000, Lot numbers:201921913, 201921915, 201921919, 201922009, 201922017, 201922019, 201922021, 201922118, 201922419, 201922120, 201922121, 201922421

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2543-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2543-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-09
Z-2544-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-15	2020-07-09

Product code OMP

K143016Class IICardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at HomeCardinalhealth / cleared 2015-04-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)