Arthroscopy Outflow/Suction Tubing 의 리콜

Recall

58017

Class 2

Z-1821-2011

2010-09-10

2011-03-25

Terminated

United States

2012-01-31

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97982

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.

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.