Home › Medical Components, Inc. › I-SERIES PD Catheter
I-SERIES PD Catheter
Medical Components, Inc. · Model MC20IS37DC · UDI-DI 00884908092264
FJS
Prescription
10
510(k) clearances
2,355
Adverse events (46 deaths)
8
Recalls
26
Facilities
Description
15F X 37CM I-SERIES STRAIGHT PERITONEAL DIALYSIS CATHETER W/2 CUFFS (CATHETER ONLY)
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.