CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine recalled
Covidien is recalling Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray/Ch Catheter, distributed nationwide in the US. The recall was initiated on 30 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1992-2020
- FDA event ID
- 85629
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2020
- FDA classified
- 14 May 2020
- Reported
- 20 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Heart & Vascular Devices
Timeline
| 30 Apr 2020 | Recall initiated by company | |
| 14 May 2020 | Classified by FDA | +14 days |
| 20 May 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it 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
Which lots are affected?
Lot Numbers: 1828206564, 1828813264 1829618264, 1829618364 1831001964, 1906506564 1907134164, 1909308864 1919705064, 1921106664 2000723764, 2003520164 2005617664
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 85629This product is part of a recall event; the main page for the event is Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter recalled.
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