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Apparatus, Suction, Patient Care
FDA product code DWM · Class 2 · Cardiovascular
65
Registered devices
1,122
Adverse events
3
Recalls
19
510(k) clearances
Devices with this code
Aspira Drainage Kit — Bard Access Systems, Inc.PleurX — CAREFUSION 2200, INCAspira® — Merit Medical Systems, Inc.ASEPT Pleural Drainage System — PFM MEDICAL INCORPORATEDPleurX — CAREFUSION 2200, INCN/A — CAREFUSION 2200, INCPleurX — CAREFUSION 2200, INCPleurX — CAREFUSION 2200, INCAspira® — Merit Medical Systems, Inc.PleurX — CAREFUSION 2200, INCRocket — ROCKET MEDICAL PLCAspira Drainage Tray — Bard Access Systems, Inc.ASEPT — PFM MEDICAL INCORPORATEDPassio Redressing Kit — Bearpac Medical, LLCAspira® — Merit Medical Systems, Inc.Aspira® — Merit Medical Systems, Inc.PleurX — CAREFUSION 2200, INCASEPT Pleural Drainage System — PFM MEDICAL INCORPORATEDAspira® — Merit Medical Systems, Inc.Passio Adapter Kit — Bearpac Medical, LLCPleurX — CAREFUSION 2200, INCASEPT® — B BRAUN INTERVENTIONAL SYSTEMS, INCAspira Drainage Tray — Bard Access Systems, Inc.Aspira Dressing Kit — Bard Access Systems, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2014-10-20 | Pfm Medical Inc | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
| 2014-10-20 | Pfm Medical Inc | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
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