Recall Z-0131-2017— ConMed Corporation
Class II · Terminated
Class II FDA medical device recall by ConMed Corporation, initiated 2016-06-27, terminated 2018-06-07. It names one FDA 510(k) clearance: K930512. Product: CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for. Reason: The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product..
- Recalling firm
- ConMed Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-27
- Terminated
- 2018-06-07
- Firm location
- Utica, NY, United States
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
CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for
Reason for recall
The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.