FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in surgical procedures (other than in neu

FDA device recall Z-2340-2008 · posted 2008-09-20 · Terminated

Recall details

Recalling firm

Baxter Bioscience

Reason for recall

The recall is being conducted as a precautionary measure due to potential discoloration of the FloSeal material noted in six (6) non-medical complaints during delivery by the Endoscopic Applicator.

Action taken

An Urgent Product Recall Letter dated August 4, 2008, was issued with attached Product Recall Instructions and Customer Response forms to all consignees (addressed to ""Risk Manager" & "Surgery"). The recall letter informed the consignees of the reason for the recall and requested their customers: 1. Examine your inventory to determine the presence of product. 2. Immediately stop dispensing and distributing this product. 3. Quarantine the product affected by this recall immediately. 4. Contact any customers who may have received the recalled shipment. 5. Carry out a physical count and record the count on the Business Reply Form. 6. Complete and Fax the enclosed Business Reply Form to 888-871-7109. 7. Return all units of the recalled product and accompanying packing slip using the prepaid UPS Return shipping label to: Stericycle, Inc. 2670 Executive Dr. Suite A Indianapolis,IN 46241 The US recall notification letters were sent via commercial carrier (UPS Next Day Service & US Postal Service Next Day Air Saver). International recall notification will utilize local contacts in each region and countries. The notifications were handled by Baxter regional representative and coordinated to be initiated in the same time. If you have questions, contact Stericycle, Inc. at 1-800-668-4391.

Root cause

Pending

Status

Terminated

Product code

LMF

Quantity affected

10,751 units worldwide (2,742 units in US)

Distribution

Nationwide and worldwide to Puerto Rico, Colombia, Hong Kong, New Zealand, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Germany, Ireland, Italy, Luxembourg, Netherlan

Date initiated

2008-07-31

Date posted

2008-09-20

Date terminated

2011-02-11

Location

Westlake Village, CA