Date Initiated by Firm |
April 30, 2020 |
Create Date |
May 14, 2020 |
Recall Status1 |
Terminated 3 on December 14, 2023 |
Recall Number |
Z-1985-2020 |
Recall Event ID |
85629 |
510(K)Number |
K933400
|
Product Classification |
Catheter, urological - Product Code KOD
|
Product |
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. |
Code Information |
Lot Number: 1909500464 |
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 |
480 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
|