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U.S. Department of Health and Human Services

Class 1 Device Recall AMS600B, AMS700B A Magellan Dispenser Tip

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  Class 1 Device Recall AMS600B, AMS700B A Magellan Dispenser Tip see related information
Date Initiated by Firm March 15, 2010
Date Posted November 18, 2010
Recall Status1 Terminated 3 on June 21, 2011
Recall Number Z-0345-2011
Recall Event ID 56874
510(K)Number K883338  
Product Classification Syringe, irrigating (non dental) - Product Code KYZ
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
Code Information Model / Lot #:  AMS600-B / 113501, AMS700-B / 113511, SA-0105 / 114156, SA-3675 / 114453 / 113532, SA-3678 / 114275.
Recalling Firm/
Manufacturer		 Micromedics, Inc.
1270 Eagan Industrial Rd Ste 120
Eagan MN 55121-1385
For Additional Information Contact
651-452-1977 Ext. 226
Manufacturer 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 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KYZ and Original Applicant = MICROMEDICS, INC.
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