Device Recall Pericardial Sump 의 리콜

Recall

46745

Class 2

Z-1175-2008

2008-01-24

2008-06-11

Terminated

United States

2013-03-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68205

Fragment of material: the product may have a loose, stainless steel stringer flash located at the distal tip of the product.

CalMed emailed letters to consignees on 1/24/2008 notifying customers of the recall. The letter advises that that the following Medical Devices are subject to an immediate Voluntary Recall for Correction: Pericardial Sump (Catalog #SU-20601), Pericardial Sump (Catalog #SU-20602), and Malleable Pericardial Sump (Catalog #SU-20802). It is asked that further distribution or use of any remaining product should cease immediately. Where appropriate, the firm asks that consignees notify their own customers who received the product of the same. The Product is being recalled due to a potentially loose, stainless steel stringer flash located at the distal tip of the Product. Customers are asked to contact the firm's Quality Assurance Manager immediately for purposes of issuing a Returned Goods Authorization and coordinating the return of the Subject Medical Devices such that they may be inspected and nonconforming product removed. A response is requested via e-mail.