Recall Z-0345-2011 ยท KYZ Syringe, Irrigating (Non Dental)
Micromedics, Inc.
AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number AMS600-B,Sterilized by Ethylene Oxide, Rx Only, Manufacturer Micromedics Inc., St. Paul, MN 55121-1385 USA, Distributor: Arteriocyte Medical Systems, Inc., 45 South Street, Hopkinton, MA 01748 USA. Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog Number AMS700-B,Sterilize
| 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 | 4025 (4295 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
| K883338 | SURGICAL SEALANT APPLICATOR Micromedics, Inc., Aug 23, 1988 |