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Basic Series Combo Pack, Large
Pensar Medical, LLC · Model 8463540 0585-CB · UDI-DI 00851978007337
OMP
Prescription
1
510(k) clearances
9,164
Adverse events (75 deaths)
47
Recalls
100
Facilities
Description
Basic Series Large Combo Pack (12 ea 0585 kits; 4 ea 0222 canisters)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-17 | KCI USA, INC. | Due to increase in complaints related to leak alarms |
| 2024-11-05 | KCI USA, INC. | Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors. |
| 2024-10-02 | Smith & Nephew Medical, Ltd. | Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. |
| 2024-03-11 | Smith & Nephew Medical, Ltd. | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
| 2024-03-11 | Smith & Nephew Medical, Ltd. | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump |
| 2020-06-08 | KCI USA, INC. | The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy. |
| 2020-06-04 | Cardinal Health 200, LLC | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| 2020-06-04 | Cardinal Health 200, LLC | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| 2019-12-02 | Medela Inc | Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. |
| 2018-02-07 | Medela Inc | Device may display a battery missing error. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.