Recall Z-3206-2018 ยท KOD Catheter, Urological
COVIDIEN LLC
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
| Date | Jul 11, 2018 |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| Action | 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 For |
| Quantity | 27515 total |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K933400 | KENDALL CURITY 100% SILICONE FOLEY CATHETER W/TEMPERATURE SENSOR Kendall Healthcare Products Co. Div.Of Tyco Health, Nov 15, 1993 |