Device Recall CalMed SU12202NS 의 리콜

Recall

63896

Class 2

Z-0650-2013

2012-11-02

2013-01-07

Terminated

United States

2013-03-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114968

California medical laboratories, inc. has identified an issue with the rigid tip suction wand. due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.

CalMed sent an Urgent Field Safety Notice dated November 2, 2012, to all affected customers by certified mail and additionally followed up via electronic mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Sorin Group USA's Customers Service Department at +1-800-650-2623 to return any unused product and order replacements. Customers were also asked to communicate the important safety information to all potential users within their organization or any other organization where the affected product may have been transferred and to maintain awareness of this communication for an appropriate period of time to ensure effectiveness of the corrective action. Customers were asked to return all unused product to CalMed Labs. Customers with questions were instructed to contact California Medical Laboratories at +1-714-556-7365. For questions regarding this recall call 714-556-7365.