Class 2 Device Recall FloSeal Endoscopic Applicator

• Date Initiated by Firm: July 31, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated on February 11, 2011
• Recall Number: Z-2340-2008
• Recall Event ID: 49104
• PMA Number: P990009
• Product Classification: Agent, absorbable hemostatic, collagen based - Product Code LMF
• Product: FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in surgical procedures (other than in neurosurgical, opthalmic, and urological) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
• Code Information: Product Code: 1500181; Lot Numbers: 05H035, 06N005, 06N017, 07A043, 07B044, 07E025, 07F010, 07G031, 07H016, 07J029, 07K034, 07N007, 088048, 08C020, 08D017, 08D053, and 08E041
• Recalling Firm/ Manufacturer: Baxter Bioscience; 1 Baxter Way; Westlake Village CA 91362-3811
• For Additional Information Contact: Ingrid Anthony-Fausset; 805-372-3247
• Manufacturer 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.
• FDA Determined Cause: Pending
• Action: 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.
• Quantity in Commerce: 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, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LMF and Original Applicant = BAXTER HEALTHCARE CORP.