400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16XTSD
FDA Recall Z-3203-2018 · Posted None
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Recalling FirmCOVIDIEN LLC
Recall StatusTerminated
Product CodeKOD
Date Initiated2018-07-11
Date Terminated2020-08-03
Product Quantity27515 total
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.
Firm 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 Form (Attachment B) regardless of whether or not you have inventory of affected product.
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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