Cook G05262Recalls & reported problems
Cook Incorporated · Acute Peritoneal Dialysis Set · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002052628), received between Dec 17, 2018 and Dec 17, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Component Missing1
- Material Twisted/Bent1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2018Component Missing; Material Twisted/Bent
IT WAS REPORTED THAT UPON OPENING OF THE PACKAGE, THE DIALYSIS SET WAS NOT IN GOOD CONDITION. IT WAS FURTHER NOTED THAT THE CAP WAS MISSING AND THE FLARE APPEARED FOLDED WHICH PREVENTED SEATING INTO THE BASE OF THE CAP. NO OTHER INFORMATION WAS MADE AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8171697 ↗
Other CATHETER, PERITONEAL devices
- ARROW IPN036986Teleflex Incorporated · CATHETER, PERITONEAL2 recalls0 reports
- CARDINAL HEALTH 30414-025Cardinal Health 200, LLC · CATHETER, PERITONEAL2 reports
- ARROW IPN032635Teleflex Incorporated · CATHETER, PERITONEAL2 reports
- Medline DYND50428Medline Industries, Inc. · CATHETER, PERITONEAL1 report
- Cook G05267Cook Incorporated · CATHETER, PERITONEAL1 report
- Super Sheath CBDE (CBDE) CI12L25TP0038Togo Medikit CO.,Ltd. · CATHETER, PERITONEAL1 report
- Tenckhoff G09085Cook Incorporated · CATHETER, PERITONEAL1 report
- CORE DYNAMICS CD8190Conmed Corporation · CATHETER, PERITONEAL1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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