—#181420

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 monitoring of temperature. Prescription use only.

FDA product code: KOD — Catheter, Urological
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K933400
Affected lot / code info: Lot Numbers: 1919708264

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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 (GMB-FieldCorrectiveAction@cardinalhealth.com) 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

Recalling firm

Firm: Covidien Llc
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2020-04-30
Terminated: 2023-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181420. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.