Z-0345-2011

AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog...

Name: Z-0345-2011 AMS600-B, AMS700-B, SA-0105, SA-3675, SA-3678 Arteriocyte Medical systems, Magellan, Cannula Tip, Catalog...
Creator: Micromedics, Inc.
Published: 2010-03-15
License: https://open.fda.gov/license/

Micromedics, Inc. / initiated 2010-03-15 / Terminated / root cause: packaging

FDA source

Micromedics, Inc. began a recall of 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... on 2010-03-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0345-2011
Status: Terminated
Initiated: 2010-03-15
Posted: 2010-11-18
Terminated: 2011-06-21
Recalling firm: Micromedics, Inc.
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
Product code: KYZ Syringe, Irrigating (Non Dental)
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.
Root cause tag: packaging
FDA 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 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.
Product codes and lots: Model / Lot #: AMS600-B / 113501, AMS700-B / 113511, SA-0105 / 114156, SA-3675 / 114453 / 113532, SA-3678 / 114275.

Product code KYZ

K883338Class ISurgical Sealant ApplicatorMicromedics, Inc. / cleared 1988-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)