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

Recall Z-2782-2018 — Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous moni

U.S. FDA — Device Enforcement · Israel · 2018-06-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2782-2018
Date of alert: 2018-06-21
Country / jurisdiction: Israel
Risk level: Class II
Risk type: recall
Brand: Degania Silicone, Ltd.
Product category: device
Product type: Devices

Reported risk: The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

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.

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