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

Recall Z-1991-2020 — Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16XTSD - Product Usage

U.S. FDA — Device Enforcement · United States · 2020-04-30 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1991-2020
Date of alert
2020-04-30
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Covidien Llc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
1828205964
Reported risk: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
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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