Company: Degania Silicone, Ltd.
Date of Enforcement Report: 1/22/2020
Class II
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.
- Recall Number: Z-0809-2020
REASON
Temperature deviation did not meet release specifications.
RECALLING FIRM/MANUFACTURER
Degania Silicone, Ltd. on 12/2/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2080 units
DISTRIBUTION
US Distribution to IL