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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo BCT

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  Class 2 Device Recall Terumo BCT see related information
Date Initiated by Firm May 04, 2012
Date Posted May 30, 2012
Recall Status1 Terminated 3 on November 27, 2012
Recall Number Z-1683-2012
Recall Event ID 57371
510(K)Number K103090  
Product Classification Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
Product Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US.

Product Usage:
For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell engraftment.
Code Information Lot numbers 1P00881 1P00545 1P00310 1P00888 1P00595 1P00652 1P00594 1P00230 1P00592 1P00804 1P00596 1P00878 1P00327 1P00166 1P00566 1P00135 1P00882 1P00681 1P00482 1P00604 1P00379 1P00422 1P00781 1P00235 1P00184 1P00441 1P00523 1P00520 1P00854 1P00795 1P00299 1P00671 1P00941 1P00461 1P00817 1P00787 1P00822 1P00672 1P00840 1P00866 1P00622 1P00389 1P00392 1P00391 1P00400 1P00394 1P00384 1P00430 1P00168 1P00933 1P00167 1P00462 1P00211 1P00162 1P00541 1P00703 1P00874 1P00591 1P00884 1P00782 1P00440 1P00646 1P00457 1P00542 1P00600 1P00147 1P00701 1P00298 1P00358 1P00393 1P00732 1P00228 1P00560 1P00177 1P00176 1P00242 1P00616 1P00387 1P00780 1P00142 1P00557 1P00172 1P00774 1P00791 1P00655 1P00511 1P00451 1P00472 1P00207 1P00669 1P00768 1P00290 1P00641 1P00534 1P00429 1P00598 1P00538 1P00515 1P00608 1P00916 1P00551 1P00353 1P00240 1P00790 1P00815 1P00268 1P00642 1P00621 1P00537 1P00361 1P00687 1P00522 1P00160 1P00512 1P00586 1P00402 1P00785 1P00731 1P00447 1P00239 1P00640 1P00453 1P00191 1P00851 1P00169 1P00606 1P00662 1P00277 1P00684 1P00311 1P00436 1P00885 1P00226 1P00302 1P00385 1P00345 1P00229 1P00803 1P00778 1P00222 1P00509 1P00666 1P00459 1P00267 1P00434 1P00141 1P00251 1P00143 1P00565 1P00382 1P00232 1P00491 1P00627 1P00553 1P00636 1P01183 1P00349 1P00981 1P00513 1P00617 1P00238 1P00639 1P00688 1P00285 1P00995 1P00810 1P01182 1P00212 1P00559 1P00982 1P00590 1P00848 1P01115 1P00900 1P01185 1P00811 1P00203 1P00605 1P00321 1P00868 1P00459 1P00267 1P00669 1P00560 1P00884 1P00141 1P00143.  
Recalling Firm/
Manufacturer		 CaridianBCT, Inc.
10811 W Collins Ave
Lakewood CO 80215-4440
For Additional Information Contact Mr. Dave Hanlon
303-239-2241
Manufacturer Reason
for Recall		 Defective product may result in decreased efficacy.
FDA Determined
Cause 2		 Component design/selection
Action Terumo BCT sent a Voluntary Medcal Device Safety Alert letter dated May 18, 2012 to each of their consignees via certified letter. The letter identified the affected product, problem, actions to be taken and instructions for healthcare providers until a corrective action is identified and implemented. Customers were instructed to share this safety alert with all those who need to be aware and complete the attached Acknowledgement Form and fax to +1.303.876.9277 or email to Terumo BCT. For questions contact your Terumo BCT Representative, the Terumo BCT Support Center at (U.S. Toll Free +1.877.339.4228) or +1.303.231.4357, or your local Terum BCT Customer Service Office.
Quantity in Commerce 372 units
Distribution US Nationwide Distribution and the country of Canada.
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 = LKN and Original Applicant = CARIDIANBCT, INC.
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