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U.S. Department of Health and Human Services

Class 2 Device Recall Covidien

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  Class 2 Device Recall Covidien see related information
Date Initiated by Firm April 30, 2020
Create Date May 14, 2020
Recall Status1 Terminated 3 on December 14, 2023
Recall Number Z-1993-2020
Recall Event ID 85629
510(K)Number K933400  
Product Classification Catheter, urological - Product Code KOD
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.
Code Information Lot Numbers: 1919708264
Recalling Firm/
Manufacturer		 Covidien Llc
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact SAME
508-261-8000
Manufacturer 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
FDA Determined
Cause 2		 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 (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
Quantity in Commerce 120 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KOD and Original Applicant = KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
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