Recall Z-0345-2011

Micromedics, Inc. · initiated March 15, 2010

Terminated

Product

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,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. Fibrijet, Applicator Tip Dual Cannula Malleable 26 ga x3" (7.6cm), Catalog Number SA-0105, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA. Fibrijet, Mixing Applicator Tip Low Viscosity with Spray Tip, Catalog Number SA-3675, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA. Fibrijet, Blending Connector with Mixer, Catalog Number SA-3678, Micromedics, Sterilized by Ethylene Oxide, Rx Only, Micromedics Inc. St Paul, MN 55121-1385 USA

Codes / lots: Model / Lot #: AMS600-B / 113501, AMS700-B / 113511, SA-0105 / 114156, SA-3675 / 114453 / 113532, SA-3678 / 114275.

Reason for recall

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.

FDA-determined cause: Packaging process control

Action taken

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.

Details

Recall number
Z-0345-2011
Initiated
March 15, 2010
Posted by FDA
November 18, 2010
Terminated
June 21, 2011
Product code
KYZ – Syringe, Irrigating (Non Dental)
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.
Recalling firm
Micromedics, Inc., Eagan, MN

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0346-2011 ATM100, LB-AP-M0001 Fibrijet, Catalog Number ATM100, Autoloous Thrombin Mixer (Blending…Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals… 03/15/2010Terminated
Z-0347-2011 SP78100, SP78105 Nasal Products, Catalog Number SP-78100, Nasal Septal Button Standard…Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals… 03/15/2010Terminated
Z-0348-2011 VT-0101-50 Otological Ventilation Tubes, Catalog Number VT-0101-50, Donaldson, with tab…Micromedics, Inc is conducting a product recall on a number of medical device products because of weak seals… 03/15/2010Terminated