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MEDCOMP PERITONEAL DIALYSIS CATHETERMEDCOMP PERITONEAL DIALYSIS CATHETER

Medical Components, Inc. · Model MPD-118 · UDI-DI 00884908030792

FJS Prescription

510(k) clearances

2,381

Adverse events (46 deaths)

Recalls

Facilities

Description

15F X 18CM STRAIGHT PERITONEAL DIALYSIS CATHETER SET W/1 CUFF

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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Data 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.