Recall Z-2544-2020 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Cardinal Health 200, LLC
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.
| Date | Jun 4, 2020 |
| Status | Terminated |
| Reason | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| 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 locatio |
| Quantity | 1960 |
| Distribution | Worldwide distribution - US Nationwide distribution and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home Cardinalhealth, Apr 20, 2015 |