Z-2469-2012Class II

Catheter Irrigation Set labeled in part: 24K Arthroscopy Outflow/Suction Tubing Set This Arthroscopy...

Name: Z-2469-2012 Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2011-07-01
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2011-07-01 / Terminated / root cause: manufacturing process

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with... on 2011-07-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2469-2012
Classification: Class II
Status: Terminated
Initiated: 2011-07-01
Posted: 2012-09-27
Terminated: 2013-07-25
Recalling firm: Linvatec Corporation
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.
Product code: GBX Catheter, Irrigation
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: ConMed Linvatec sent a Urgent Medical Device Recall Notification via FedEx to all affected customers. This notice should be received July 5, 2011. The letter identified the product the problem and the action needed to be taken by the customer. All returned product under this removal action will be identified, segregated, and quarantined per ConMed Utica, N.Y. procedures. Returned product will be dispositioned in accordance with ConMed Utica, N.Y. procedures. This can include repackaged and resterilization with new lot number or product scrap. ConMed Utica, N.Y. will maintain control of all individual lot numbers returned and dispositioned. Firm is striving for 1005 effectiveness. If a Reply form is not received within approximately 30 days of the first mailing, ConMed Linvatec will make two additional contacts by mail approximately 30-35 days apart. Should you have any additional questions please contact our Customer Service at 800-237-0169 or fax at 727-319-5701.
Quantity in commerce: 30064 units
Distribution: Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, WA ,WI and Hawaii., and the countries of Australia Canada, China, Switzerland, Germany, Czech Republic, Denmark, Egypt, Spain, France, South Africa, United Kingdom, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russia and Saudi Arabia.
Product codes and lots: Catalog # 24k100 Lot #: 20853-000 20854-000 20855-000 21791-000 22172-000 22414-000 22513-000 22667-000 22724-000 22725-000 23606-000 23912 23912-000 23971-000 24177-000 24296-000 24348-000 24373-000 24476-000 24559-000 24671-000 24703-000 24905-000 25668-000 25794-000 25931-000 26025-000 26041-000 26294-000 26448-000 26486-000 27130-000 27255 27255-000 27322 27520

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2469-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2469-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-27

Product code GBX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)