Z-0809-2020 Class II Terminated

Recalled by Degania Silicone, Ltd. — Dganya Bet

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