Recall Z-0809-2020— Degania Silicone, Ltd.
Class II · Terminated
Class II FDA medical device recall by Degania Silicone, Ltd., initiated 2019-12-02, terminated 2020-10-22. It names one FDA 510(k) clearance: K063442. 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: Temperature deviation did not meet release specifications.
- Recalling firm
- Degania Silicone, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-02
- Terminated
- 2020-10-22
- Firm location
- Dganya Bet, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.