Recall Z-0346-2011 ยท KYZ Syringe, Irrigating (Non Dental)
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.
| Date | Nov 18, 2010 (initiated Mar 15, 2010) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K881020 | SURGICAL SEALANT DISPENSER (SSD) Micromedics, Inc., Mar 25, 1988 |