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

FDA device recall Z-2469-2012 · posted 2012-09-27 · Terminated

Recall details

Recalling firm

Linvatec Corp. dba ConMed Linvatec

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.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

GBX

Quantity affected

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 Hawa

Date initiated

2011-07-01

Date posted

2012-09-27

Date terminated

2013-07-25

Location

Largo, FL