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U.S. Department of Health and Human Services

Class 2 Device Recall Temperature sensor catheters

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 Class 2 Device Recall Temperature sensor catheterssee related information
Date Initiated by FirmJuly 11, 2018
Create DateSeptember 20, 2018
Recall Status1 Terminated 3 on August 03, 2020
Recall NumberZ-3205-2018
Recall Event ID 80747
510(K)NumberK933400 
Product Classification Catheter, urological - Product Code KOD
Product400mL, Premium, Urine Meter, 14 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P14TSD
Code Information 1733152764 1806451564
FEI Number 1282497
Recalling Firm/
Manufacturer		 COVIDIEN LLC
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information ContactCustomer Advocacy
800-292-9332
Manufacturer Reason
for Recall		The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 7/11/18, an Urgent Medical Device Recall letter was distributed to customers. The letter instructed customers to do the following: 1. Please quarantine any unused product of the Covidien item codes and lot numbers listed above (see Attachment A to locate). 2. If you have distributed any of the affected Covidien catheters or kits, then please promptly forward a copy of this letter to those recipients. 3. All unused product of affected item codes and lot numbers must be returned. 4. Please return unused affected product as explained below. You must complete the Recalled Product Return Form (Attachment B) regardless of whether or not you have inventory of affected product.
Quantity in Commerce27515 total
DistributionThe products were distributed to the following US states: CA, CO, FL, GA, IA, IL, IN, KY, LA, MA, MD, MO, NC, NJ, NY, OH, OR, PA, RI, SC, TN, TX, VA, and WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KOD
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