CLASS II Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
Temp Sense Silicone 14fr5cc2w recalled by Covidien
Covidien is recalling Temp Sense Silicone 14fr5cc2w, distributed in 24 states. The recall was initiated on 11 Jul 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3204-2018
- FDA event ID
- 80747
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jul 2018
- FDA classified
- 20 Sep 2018
- Reported
- 26 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 11 Jul 2018 | Recall initiated by company | |
| 20 Sep 2018 | Classified by FDA | +71 days |
| 26 Sep 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T
Where it was distributed
The 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.
CaliforniaColoradoFloridaGeorgiaIowaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMissouriNorth CarolinaNew JerseyNew YorkOhioOregonPennsylvaniaRhode IslandSouth Carolina
Questions about this recall
Is Temp Sense Silicone 14fr5cc2w recalled?
Yes. Covidien recalled Temp Sense Silicone 14fr5cc2w on 11 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-3204-2018.
Why was it recalled?
The temperature sensor catheters may be defective in that they will show a lower body temperature measurement than the actual temperature of the patient.
Which lots are affected?
1733850164 1805050064
Where was it sold?
The 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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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