seprafilm Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is indicated f

FDA device recall Z-1856-2012 · posted 2012-06-21 · Terminated

Recall details

Recalling firm

Genzyme Corporation

Reason for recall

Sterility of product may be compromised due to packaging defect

Action taken

Genzyme issued an Urgent: Medicatical Device Product Recall Notification Letter dated June 13, 2012 to all affected customers. Stericycle Expert Solutions, will be acting on behalf of Genzyme to coordinate notifications, communications, and logistics for returns of all product subject to this recall. The letter identified the affected products, problen and actions to be taken. Customers are requested to check their inventory and return all affected products per the instructions provided. Customers are instructed to complete the enclosed Business Reply Form and return via fax transmission to 866-912-2519. For questions call Stericycle at: 877- 473-7069.

Root cause

Packaging process control

Status

Terminated

Product code

MCN

Quantity affected

1285 units

Distribution

Worldwide Distribution - US (nationwide) and the country of S. Korea

Date initiated

2012-06-13

Date posted

2012-06-21

Date terminated

2013-07-24

Location

Framingham, MA