FDA (Devices) recall action 85629

Covidien Llc recalled 11 products on 2020-05-20

The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.

Products: 11
Announced: 2020-05-20
Critical: 0
Units: 132,955

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–11 of 11

HighFDA (Devices)··2020-05-20
Dover Silicone Foley Catheters Recalled for Temperature Measurement Failures
FDA is recalling Dover 100% Silicone Foley Catheters because they failed to meet temperature sensing tolerances, potentially leading to incorrect diagnoses.
Product
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
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0 states
HighFDA (Devices)··2020-05-20
Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
FDA is recalling Dover silicone Foley catheters because temperature sensors failed to meet calibration standards, risking incorrect patient diagnoses.
Product
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 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: P4P16TSD - Product Usage: for Drainage of the U
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0 states
HighFDA (Devices)··2020-05-20
Dover Foley Catheter Recalled for Temperature Sensor Calibration Failures
Covidien is recalling Dover Foley catheters with temperature sensors that failed to meet calibration tolerances, posing a risk of incorrect diagnosis.
Product
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
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0 states
HighFDA (Devices)··2020-05-20
FDA Recalls Dover Foley Catheters Due to Temperature Sensor Failures
FDA is recalling Dover Foley catheters because their temperature sensors failed to meet calibration standards, which could lead to incorrect patient diagnoses.
Product
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 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:
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0 states
HighFDA (Devices)··2020-05-20
Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
FDA recalls 468 Dover Foley catheters with temperature sensors that failed accuracy tests. Incorrect readings could lead to misdiagnosis.
Product
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
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0 states
HighFDA (Devices)··2020-05-20
Dover Foley Catheters Recalled for Temperature Sensor Inaccuracy
FDA is recalling 480 Dover Foley catheters with temperature sensors that failed to meet accuracy standards, posing a risk of incorrect patient diagnosis.
Product
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Category
Distribution
0 states
HighFDA (Devices)··2020-05-20
Recall of Dover Foley Catheters Due to Temperature Sensor Inaccuracy
FDA is recalling specific Dover Foley catheters because their temperature sensors failed to meet calibration standards, potentially leading to incorrect patient diagnoses.
Product
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P18XTSD - Product Usage:
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0 states
SevereFDA (Devices)··2020-05-20
FDA Recalls Dover Foley Catheters Due to Temperature Sensor Inaccuracy
The FDA is recalling specific lots of Dover Foley catheters because their temperature sensors may not measure accurately. This could lead to incorrect patient diagnoses.
Product
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 P4P16
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0 states
HighFDA (Devices)··2020-05-20
Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
Covidien is recalling Dover 100% Silicone Foley trays because the temperature sensors failed to meet calibration standards, potentially leading to incorrect patient diagnoses.
Product
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P14TSD - Product Usage: for Drainage of the Ur
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0 states
HighFDA (Devices)··2020-05-20
Recall of Dover Foley Catheters Due to Temperature Sensor Inaccuracy
FDA is recalling 120 units of Dover Foley catheters because temperature sensors failed to meet calibration standards, potentially leading to incorrect diagnoses.
Product
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P18XTS - Product Usage: for Drainage of the Urinary bladder and simultaneous m
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0 states
HighFDA (Devices)··2020-05-20
Dover Silicone Foley Catheter Recall for Temperature Sensor Inaccuracy
FDA is recalling Dover silicone Foley catheters with temperature sensors that failed to meet calibration standards, posing a risk of incorrect patient diagnosis.
Product
Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature
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Distribution
0 states