Recalls / —
—#166442
Product
TEMP SENSE SILICONE 14FR5CC2W, Item Code 50514T
- FDA product code
- KOD — Catheter, Urological
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K933400
- Affected lot / code info
- 1733850164 1805050064
Why it was 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.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
On 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.
Recalling firm
- Firm
- COVIDIEN LLC
- Address
- 15 Hampshire St, Mansfield, Massachusetts 02048-1113
Distribution
- Distribution pattern
- 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.
Timeline
- Recall initiated
- 2018-07-11
- Terminated
- 2020-08-03
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #166442. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.