Recall Z-1129-2015— Cincinnati Sub-Zero Products Inc
Class II · Terminated
Class II FDA medical device recall by Cincinnati Sub-Zero Products Inc, initiated 2015-01-07, terminated 2015-06-19. It names 2 FDA 510(k) clearances: K902269, K843146. Product: Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.. Reason: Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak..
- Recalling firm
- Cincinnati Sub-Zero Products Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-07
- Terminated
- 2015-06-19
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
2 on FDA's record- K902269 — ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY
- K843146 — MICRO-TEMP PUMPS & MICRO-TEMP PADS
K-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
Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.
Reason for recall
Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
Data sourced from openFDA. This site is unofficial and independent of the FDA.