Device Recall CENTURION CENTRAL LINE PROCEDURE KIT 의 리콜

Recall

58346

Class 2

Z-2327-2011

2011-03-31

2011-05-27

Terminated

United States

2011-09-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99107

This voluntary sub-recall was initiated because the vials of bacteriostatic sodium chloride injection, usp, 0.9% utilized to make the products may contain visible particulates.

Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits. Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession. Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account. For any questions regarding this recall call 631-924-4000, ext 142.