ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx recall
ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems
Why was ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx recalled?
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: SP-3013-00; SP-3013-01; SP-3013-02; SP-3013-03. Serial Numbers: 200042, 200044, 200014, 200056, 200064, 200055, 200044, 200038, 200013, 310009, 310007, 20043, 200145, 200144.
- Product
- ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems
- Recalling firm
- The Anspach Effort, Inc.
- Quantity
- 113
- Distribution
- Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .
- Recall date
- July 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)