AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to
Hazard
Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed.
What You Should Do
Remedy
Urgent Recall letters, dated 09/01/05, were sent to affected customers via email, facsimile and with follow-up delivery via USPS. OUS customers were notified via Federal Express. The letter described the situation, the lots being recalled and included a response form that was to be faxed back to AGA Medical.
Affected by this recall?
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Products
AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages
- Brand
- AGA Medical Corporation
- UPC
- The three lots that were distributed are identified as Lot no. M05F10-11, M05F15-12 and M05F02-47.
Units Affected
81