Recall – Displayed temperature deviation did not meet released specifications

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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.