FDA Medical Device Recalls (openFDA)
Micromedics, Inc.: ATM100, LB-AP-M0001 Fibrijet, Catalog Number ATM100, Autoloous Thrombin Mixer (Blending Connector), Micromedics, Sterilized by Ethylene Oxide, Rx Only, MicromedicsInc., St Paul, MN 55121-1385. Distributed by Lifebond, P.O. Box 3048 Caesarea Industrial Park 38900, Israel, LP-AP-M0001, LifeSeal SLR Applicator Sterilized by Ethylene Oxide, Manufactured By Micromedics, St Paul, MN 55121-1385 USA.
- Recall number
- Z-0346-2011
- Recalling firm
- Micromedics, Inc.
- Product
- ATM100, LB-AP-M0001 Fibrijet, Catalog Number ATM100, Autoloous Thrombin Mixer (Blending Connector), Micromedics, Sterilized by Ethylene Oxide, Rx Only, MicromedicsInc., St Paul, MN 55121-1385. Distributed by Lifebond, P.O. Box 3048 Caesarea Industrial Park 38900, Israel, LP-AP-M0001, LifeSeal SLR Applicator Sterilized by Ethylene Oxide, Manufactured By Micromedics, St Paul, MN 55121-1385 USA.
- Status
- Terminated
- Initiated
- 2010-03-15
- Posted
- 2010-11-18
- Terminated
- 2011-06-21
- Reason
- Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals of the sterile pouches potentially resulting in a non-sterile product which may cause transmission of disease or infection.
- Root cause
- Packaging process control
- Action
- Micromedics issued a Product Recall letter dated March 15, 2010 to customers, describing the product being recalled, the product sterility issue, and actions to be taken. The letter advised customers to contact Customer service to return any affected product to Micromedics for replacement. Customers can contact Micromedics at 1-800-624-5662 or 651-452-1977 ext. 226 concerning this recall.
- Quantity
- 620 (800 pouches)
- Distribution
- Nationwide Distribution in the states of CA, CT, DE, FL, GA, ID, IL, IN, MD, MA, MI, MN, NJ, NY, NC, PA, TX, UT, and WI. FRANCE, NETHERLANDS, BELGIUM, UNITED KINGDOM, CANADA, ISRAEL, PERU, SPAIN, IRELAND.
- Lot, serial or model codes
- Model / Lot #: ATM100 / 112711 LB-AP-M0001 / 114097.
- 510(k) numbers
- ["K881020"]
- PMA numbers
- not on file
- Product code
- KYZ
- Firm FEI
- 2183425
- Firm city
- Eagan
- Firm state
- MN
- 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