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: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
Recall
- Recall Number
- Z-1991-2020
- Event Number
- 85629
- Firm
- Covidien Llc
- FEI Number
- 1282497
- Product Code
- KOD
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 30, 2020
- Terminated
- December 14, 2023
- Address
- 15 Hampshire St, Mansfield, MA, 02048-1113
Description
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: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
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
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
US Nationwide distribution.
46828 units