—#166444

Product

400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD

FDA product code: KOD — Catheter, Urological
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K933400
Affected lot / code info: 1733952664 1735258064

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 #166444. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.