CARDINAL HEALTH JP-HUR195Recalls & reported problems
Cardinal Health 200, LLC · JP HEMADUCT 19FR W/15FR TROCAR · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885380064135), received between Jun 28, 2017 and Jun 28, 2017 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection3
- Abdominal Pain1
- Bacterial Infection1
- Fever1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 28, 2017Insufficient Device Problem Information
CUSTOMER HAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION AFTER HAVING A JACKSON PRATT DRAIN PLACED. CUSTOMER REPORTS THAT A FEMALE PATIENT AGE (B)(6) HAD A JACKSON PRATT DRAIN PLACED FOLLOWING AN ABDOMINAL PLASTI PROCEDURE. DRAIN WAS PLACED ON (B)(6) 2017 AND REMOVED ON (B)(6) 2017 AND PATIENT HAD A FEVER AND BACK PAIN AND WAS FOUND TO HAVE A STAPH INFECTION AND WAS HOSPITALIZED. FACILITY DOES NOT TRACK LOT NUMBER AND IS REPORTING PRODUCT WAS EITHER PRODUCT NUMBER SU130-1411 OR JP-HUR195.
Patient problems: Bacterial Infection; Pain; Unspecified Infection
MAUDE report 6675272 ↗InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem
CUSTOMER HAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION AFTER HAVING A JACKSON PRATT DRAIN PLACED. CUSTOMER REPORTS THAT A FEMALE PATIENT AGE 39 HAD A JACKSON PRATT DRAIN PLACED FOLLOWING AN ABDOMINAL PLASTIC PROCEDURE. DRAIN WAS PLACED ON (B)(6) 2016 AND REMOVED ON (B)(6) 2016 AND THE PATIENT RETURNED TO THE HOSPITAL DUE TO ABDOMINAL PAIN AND A FEVER. PATIENT WAS HOSPITALIZED AND THE DRAIN WAS REMOVED AND A NEW DRAIN PLACED ON (B)(6)2016. PATIENT WAS GIVEN ANTIBIOTICS DUE TO A STAPH INFECTION. FACILITY DOES NOT TRACK LOT NUMBER AND IS REPORTING PRODUCT WAS EITHER PRODUCT NUMBER SU130-1411 OR JP-HUR195.
Patient problems: Abdominal Pain; Fever; Unspecified Infection
MAUDE report 6675244 ↗InjuryJun 28, 2017Insufficient Device Problem Information
CUSTOMER REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION AFTER HAVING A JACKSON PRATT DRAIN PLACED. CUSTOMER REPORTS THAT A FEMALE PATIENT AGE (B)(6) HAD A JACKSON PRATT DRAIN PLACED FOLLOWING AN ABDOMINAL PLASTI PROCEDURE. DRAIN WAS PLACED ON (B)(6) 2017 AND REMOVED ON (B)(6) 2017 AND THE PATIENT RETURNED TO THE HOSPITAL DUE TO DRAINAGE. PATIENT WAS GIVEN ANTIBIOTICS DUE TO INFECTION ACCORDING TO THE NURSE. FACILITY DOES NOT TRACK LOT NUMBER AND IS REPORTING PRODUCT WAS EITHER PRODUCT NUMBER SU130-1411 OR JP-HUR195.
Patient problems: Unspecified Infection
MAUDE report 6674595 ↗
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- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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