Angiotech***Custom Bone Marrow Tray for High Point Regional Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 -

FDA device recall Z-0235-2012 · posted 2011-11-18 · Terminated

Recall details

Recalling firm

Medical Device Technologies, Inc.

Reason for recall

Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity.

Action taken

The firm, Angiotech, sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated December 22, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review their current inventory, segregate the affected lot numbers and complete and return the attached Customer Acknowledgement Form via fax to our Quality Assurance department at 1.352.338.0662 or 1.800.333.0440 to arrange for return of the identified product. If you have any questions concerning this notification, call (352) 338.0440 ext. 355 or ext 358.

Root cause

Packaging

Status

Terminated

Product code

OJV

Quantity affected

105 boxes

Distribution

Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.

Date initiated

2010-12-22

Date posted

2011-11-18

Date terminated

2011-11-30

Location

Gainesville, FL