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.
FDA Recall Z-0809-2020 · Posted None
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Recalling FirmDegania Silicone, Ltd.
Recall StatusTerminated
Product CodeEZL
Date Initiated2019-12-02
Date Terminated2020-10-22
Product Quantity2080 units
Reason for Recall
Temperature deviation did not meet release specifications
Firm Action
The firm, Q Medical Degania issued an "URGENT FIELD SAFETY NOTICE" letter dated 02-DEC-2019 via email, the letter states reason for recall, health risk and action to take: Please forward this information to the immediate attention of the persons responsible for usage of the affected parts. Sub-recall must be initiated by your company to collect any distributed product from the suspected list.
2. Please fill in the attached Recall Response form and indicate the quantity of the affected product in your possession.
3. Please promptly return the completed Recall Response form to Degania Silicone by e-mail: [email protected].
4. The disposition of the recalled goods should be scrap. We would ask you to destruct the goods at your facility and send us the Scrap confirmation letter.
Should you have any questions about this subject, please contact Degania Silicone: Degonia Silicone ltd. Degania Bet, 1513000, ISRAEL
Katia Kayam, Customer complaints Officer, Tel: +972-529532059
E-mail: [email protected]
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Distribution to IL
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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