Device product
Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.
Z-0809-2020
Product summary
- Event
- Event 84510
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2080 units
- Official record key
device-enforcement:Z-0809-2020
Official wording
Reason: Temperature deviation did not meet release specifications
Code information: Lot Number: V18046701
Distribution pattern: US Distribution to IL
Derived failure modes
-
Unknown
Temperature deviation did not meet release specifications