FDAClass IIJuly 12, 2017

Nussloch GmbH ASP6025 Tissue Processor recall: Labeling Error

Nussloch GmbH ASP6025 Tissue Processor

Why was Nussloch GmbH ASP6025 Tissue Processor recalled?

Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Serial No. 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 238, 240, 242, 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 290, 292, 294, 296, 298, 300, 302, 304, 308, 312, 320, 334, 336, 338, 340, 342, 352, 354, 356, 358, 360, 362, 364, 366, 368, 370, 372, 374, 378, 380, 382, 384, 386, 388, 396, 400, 402, 406, 408, 418, 420, 422, 424, 426, 428, 432, 434, 438, 440, 442, 444, 450, 452, 454, 456, 460, 462, 464, 468, 478, 480, 482, 484, 486, 488, 490, 492, 498, 502, 504, 516, 526, 530, 536, 544, 546, 548, 550, 554, 556, 558, 560, 562, 564, 570, 572, 574, 576, 580, 582, 584, 586, 588, 590, 598, 604, 612, 614, 628, 632, 636, 640, 642, 646, 650, 654, 660, 662, 666, 668, 674, 676, 684, 686, 692, 694, 696, 698, 700, 702, 704, 706, 712, 718, 720, 726, 728, 730, 732, 734, 736, 738, 742, 744, 746, 770, 784, 794, 796, 808, 810, 814, 816, 818, 820, 824, 834, 858, 860, 864, 866, 868, 870, 874, 878, 886, 892, 314, 316, 448, 538, 594, 622, 712, 778.

Product
Nussloch GmbH ASP6025 Tissue Processor
Recalling firm
Leica Microsystems, Inc.
Quantity
812 units
Distribution
Domestic: AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV, & DC. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, England, France, Georgia, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lithuania, Malaysia, Maldives, Mexico, Morocco, Myanmar, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, & United Arab Emirates.
Recall date
July 12, 2017
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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