Z-2340-2008

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

Name: Z-2340-2008 FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in surgical procedures (other...
Creator: Baxter Bioscience
Published: 2008-07-31
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2008-07-31 / Terminated

FDA source

Baxter Bioscience began a recall of FloSeal Endoscopic Applicator , Product Code 1500181. The product is indicated in surgical procedures (other than in neurosurgical, opthalmic, and urological)... on 2008-07-31. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2340-2008
Status: Terminated
Initiated: 2008-07-31
Posted: 2008-09-20
Terminated: 2011-02-11
Recalling firm: Baxter Healthcare Corporation
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.
Product code: LMF Agent, Absorbable Hemostatic, Collagen Based
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 root 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.
Product codes and lots: Product Code: 1500181; Lot Numbers: 05H035, 06N005, 06N017, 07A043, 07B044, 07E025, 07F010, 07G031, 07H016, 07J029, 07K034, 07N007, 088048, 08C020, 08D017, 08D053, and 08E041

Product code LMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)