Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0512-2020 — Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

U.S. FDA — Device Enforcement · United Kingdom · 2019-08-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0512-2020
Date of alert
2019-08-01
Country / jurisdiction
United Kingdom
Risk level
Class II
Risk type
recall
Brand
Rocket Medical Plc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
05055270913678
Reported risk: A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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