Skip to content

FloSeal Endoscopic Applicator , Product Code 1500181. The… recallZ-2340-2008 · Baxter Bioscience · initiated Jul 31, 2008

Terminated All recalls posted in September 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Bioscience or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Pending

What the company is doing

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.

Recall details

Recall number
Z-2340-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 31, 2008
Posted by the FDA
Sep 20, 2008
Recalling firm
Baxter Bioscience
Quantity
10,751 units worldwide (2,742 units in US)
Product code
LMF
FDA submissions
P990009
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.

Product description

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 (models, lots, serial numbers)

Product Code: 1500181; Lot Numbers: 05H035, 06N005, 06N017, 07A043, 07B044, 07E025, 07F010, 07G031, 07H016, 07J029, 07K034, 07N007, 088048, 08C020, 08D017, 08D053, and 08E041

Other devices under the same FDA submission

4 devices cleared under P990009 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page