Recall Z-2469-2012— Linvatec Corp. dba ConMed Linvatec
Class II · Terminated
Class II FDA medical device recall by Linvatec Corp. dba ConMed Linvatec, initiated 2011-07-01, terminated 2013-07-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.. Reason: ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents..
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-07-01
- Terminated
- 2013-07-25
- Firm location
- Largo, FL, United States
Product description
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
Reason for recall
ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a breach in the Tyvek seal that could potentially compromise the sterility of the contents.
Data sourced from openFDA. This site is unofficial and independent of the FDA.