FDA Medical Device Recalls (openFDA)
Baxter Bioscience: 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.
- Recall number
- Z-2340-2008
- Recalling firm
- Baxter Bioscience
- 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.
- Status
- Terminated
- Initiated
- 2008-07-31
- Posted
- 2008-09-20
- Terminated
- 2011-02-11
- Reason
- 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.
- 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
- 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.
- Lot, serial or model codes
- Product Code: 1500181; Lot Numbers: 05H035, 06N005, 06N017, 07A043, 07B044, 07E025, 07F010, 07G031, 07H016, 07J029, 07K034, 07N007, 088048, 08C020, 08D017, 08D053, and 08E041
- 510(k) numbers
- not on file
- PMA numbers
- P990009
- Product code
- LMF
- Firm FEI
- 1417572
- Firm city
- Westlake Village
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28