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

Recall Z-1781-2020 — Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

U.S. FDA — Device Enforcement · India · 2020-03-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1781-2020
Date of alert: 2020-03-17
Country / jurisdiction: India
Risk level: Class II
Risk type: recall
Brand: Degania Medical Devices Pvt. Ltd.
Product category: device
Product type: Devices

Reported risk: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1781-2020 — Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

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