CARDINAL HEALTH SU130-401DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253016413), received between Jun 12, 2024 and Jun 12, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Microbial Contamination of Device” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 27, 2024Open, Classified

   Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.

   Z-1735-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2024Microbial Contamination of Device; Microbial Contamination of Device

  MW5154606: CUSTOMER REPORTED A PATIENT HAD A RIGHT ANTERIOR TOTAL HIP ARTHROPLASTY ON (B)(6) 2024, IN WHICH A JACKSON-PRATT 3-SPRING RESERVOIR KIT WITH PVC ROUND DRAIN, 7FR DISTRIBUTED BY CARDINAL HEALTH WAS PLACED. ON (B)(6) 2024 WE WERE NOTIFIED BY CARDINAL HEALTH OF A PRODUCT RECALL DUE TO PRODUCT NOT BEING STERILIZED PRIOR TO DISTRIBUTION. THIS PATIENT OBTAINED A POST OPERATIVE INFECTION DIAGNOSED AND WAS STARTED ON ORAL ANTIBIOTICS. PATIENT RECEIVED MULTIPLE DEBRIDEMENT¿S IN OFFICE AND EVENTUALLY REQUIRED NEGATIVE PRESSURE WOUND THERAPY. THIS PATIENT IS BELIEVED TO HAVE RECEIVED A NON-STERILE DRAIN RESULTING IN SURGICAL COMPLICATIONS. A WOUND CULTURE OBTAINED FROM A SURGICAL WOUND SHOULD HAVE NO GROWTH.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19525214 ↗
• InjuryJun 12, 2024Microbial Contamination of Device; Microbial Contamination of Device

  MW5154605: CUSTOMER REPORTED A PATIENT HAD A RIGHT ANTERIOR TOTAL HIP ARTHROPLASTY ON (B)(6) 2024, IN WHICH A JACKSON-PRATT 3-SPRING RESERVOIR KIT WITH PVC ROUND DRAIN, 7FR DISTRIBUTED BY CARDINAL HEALTH WAS PLACED. ON 3/28/24 WE WERE NOTIFIED BY CARDINAL HEALTH OF A PRODUCT RECALL DUE TO PRODUCT NOT BEING STERILIZED PRIOR TO DISTRIBUTION. THIS PATIENT OBTAINED A POST OPERATIVE INFECTION DIAGNOSED AND WAS STARTED ON ORAL ANTIBIOTICS. PATIENT RECEIVED MULTIPLE DEBRIDEMENT¿S IN OFFICE AND EVENTUALLY REQUIRED NEGATIVE PRESSURE WOUND THERAPY. THIS PATIENT IS BELIEVED TO HAVE RECEIVED A NON-STERILE DRAIN RESULTING IN SURGICAL COMPLICATIONS. A WOUND CULTURE OBTAINED FROM A SURGICAL WOUND SHOULD HAVE NO GROWTH.

  Patient problems: Post Operative Wound Infection

  MAUDE report 19525206 ↗