Z-0809-2020 Class II Terminated
FDA device recall Z-0809-2020 was initiated by Degania Silicone, Ltd. on December 2, 2019 and is designated Class II. Reason for recall: Temperature deviation did not meet release specifications The recall status is terminated (terminated October 22, 2020). Affected quantity: 2080 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2020
- Initiation Date
- December 2, 2019
- Termination Date
- October 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2080 units
Product Description
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.
Reason for Recall
Temperature deviation did not meet release specifications
Distribution Pattern
US Distribution to IL
Code Information
Lot Number: V18046701