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U.S. Department of Health and Human Services

Class 2 Device Recall ReliaMed Deluxe Portable Adjusting Table

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 Class 2 Recall
ReliaMed Deluxe Portable Adjusting Table
see related information
Date Posted August 26, 2010
Recall Status1 Terminated on February 16, 2012
Recall Number Z-2288-2010
Recall Event ID 55772
Product Classification Board, Bed - Product Code FPS
Product ReliaMed Deluxe Portable Adjusting Table. Product is a medical table used on patients for massage and chiropractic treatment.
Code Information The table do not bear lot or serial numbers; however there are two device identification numbers representative of two different colors. ZZRNT100BL (blue) ZZRMT100BLK (black)
Recalling Firm/
Manufacturer
MDC Acquisition Co.
8595 Milliken Ave Ste 101
Rancho Cucamonga, California 91730-4942
Manufacturer Reason
for Recall
Two complaints were received of the vinyl-covered, padded, plywood table surface breaking near the foot end.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action "Urgent: Medical Device Recall" letters were sent to consignees from Milliken Medical and Meyer Distributing Company in April 2010 describing the issue. They instructed their customers to immediately stop use of the table. customers were instructed to return the tables to the firm with an enclosed Recall Form for future replacement, or for replacement with a comparable table from another menufacturer at no cost, or for refund of the original cost of the device. Consignees may contact Meyer Distributing Company at 800-472-4221 and Milliken Medical at 800-532-1356.
Quantity in Commerce 265 Tables
Distribution Worldwide distribution: USA, including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA and WI, and the country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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