Z-1994-2020Class II

Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL...

Name: Z-1994-2020 Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL...
Creator: Covidien Llc
Published: 2020-04-30
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2020-04-30 / Terminated / root cause: manufacturing process

FDA source

Covidien Llc began a recall of 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... on 2020-04-30. FDA classified it as Class II and gives the reason as "Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1994-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-30
Posted: 2020-05-14
Terminated: 2023-12-14
Recalling firm: Medtronic, Inc.
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: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Product code: KOD Catheter, Urological
Reason for recall: Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Cardinal Health issued letter Urgent Medical Device Recall EVENT-2020-02846 on 4/30/20 via overnight mail. Letter states reason for recall, health risk, and action to take: 1. CHECK all storage and usage locations to confirm whether you have any units of the affected product codes and lot numbers 2. SEGREGATE and QUARANTINE all on-hand product that is confirmed to be labeled per Exhibit A. 3. PLEASE RETURN the enclosed acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email ([email protected]) and indicate the product code, lot and quantity of product youve quarantined or discarded. Please respond regardless of whether or not you have affected product. 4. NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST: Hospital800-964-5227 Federal Government800-444-1166 Distributor800-635-6021 All other Customers888-444-5440 Questions contact: Cardinal Health 800-292-9332
Quantity in commerce: 0
Distribution: US Nationwide distribution.
Product codes and lots: Lot Numbers: 1914133564

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1994-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1984-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1985-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1986-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1987-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1988-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1989-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1990-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1991-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1992-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1993-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1994-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14

Product code KOD

K933400Class IIKendall Curity 100% Silicone Foley Catheter W/temperature SensorKendall Healthcare Products Co. Div.Of Tyco Health / cleared 1993-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)