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Argyle
Mozarc Medical US LLC · Model 8811313009 · UDI-DI 10884521054875
FJS
Prescription
2
510(k) clearances
2,381
Adverse events (46 deaths)
8
Recalls
26
Facilities
Description
Peritoneal Dialysis Catheter,Curl Cath, 2 Loose Cuffs
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-15 | Merit Medical Systems, Inc. | Product that was built for design verification testing was inadvertently distributed to customers. |
| 2017-12-20 | Merit Medical Systems, Inc. | Mix-up between adult and pediatrics PD catheter. |
| 2017-09-20 | Merit Medical Systems, Inc. | 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product. |
| 2014-10-20 | Pfm Medical Inc | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. |
| 2011-05-21 | Bard Access Systems | Labeling for drainage kit contained incomplete information. |
| 2011-05-21 | Bard Access Systems | Labeling for drainage kit contained incomplete information. |
| 2011-05-21 | Bard Access Systems | Labeling for drainage kit contained incomplete information. |
| 2011-05-21 | Bard Access Systems | Labeling for drainage kit contained incomplete information. |
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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.