***REF 24k100***QTY 1***24k Arthroscopy Outflow/Suction Tubing Set***MADE IN USA***Rx Only***CONMED LINVATEC, CONMED LIN

FDA device recall Z-1821-2011 · posted 2011-03-25 · Terminated

Recall details

Recalling firm

Linvatec Corp. dba ConMed Linvatec

Reason for recall

On 09/13/2010 ConMed Linvatec, Largo, FL initiated a recall on 24k100 Arthroscopy Outflow/Suction Tube Set used with the ConMed Linvatec 24k Pump. The 24k100 Arthroscopy Outflow/Suction Tubing Set Lots 22747-000, 22748-000, and 2749-000 may have been incorrectly assembled and could potentially allow waste to enter the sterile field.

Action taken

Linvatec Corp. dba ConMed Linvatec sent an Urgent Medical Device Recall Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their facility's inventory for the affected product. If they had any of the product they were instructed not to use and segregate the product and return for credit. Return the affected products and the completed REPLY FORM to their local ConMed Linvatec office. If the product was transferred to another facility, customers were instructed to complete the REPLY FORM documenting the transfer of the product and mail or fax the REPLY FORM to their local ConMed Linvatec office at 727-319-5701. If the customers do not have the affected product they should complete the REPLY FORM and mail in the enclosed envelope or fax to 727-319-5701.

Root cause

Other

Status

Terminated

Product code

JCY

Quantity affected

4,598

Distribution

Worldwide Distribution - USA (nationwide) and internationally to Saudi Arabia, Italy, France, Canada, Portugal, South Africa, Switzerland, Denmark, Germany, New Zealand, Australia, and Spain.

Date initiated

2010-09-10

Date posted

2011-03-25

Date terminated

2012-01-31

Location

Largo, FL