FDA recall Z-0809-2020

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.

Reason for recall

Temperature deviation did not meet release specifications

Distribution

US Distribution to IL

Key facts

Status

Terminated

Initiation date

2019-12-02

Report date

2020-01-22

Termination date

2020-10-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dganya Bet, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0809-2020