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