| Class 2 Device Recall Lift Chairs | |
Date Initiated by Firm | June 07, 2004 |
Date Posted | November 19, 2004 |
Recall Status1 |
Terminated 3 on August 10, 2006 |
Recall Number | Z-0212-05 |
Recall Event ID |
29344 |
510(K)Number | K821827 K852864 K931349 K953342 |
Product Classification |
Chair, Positioning, Electric - Product Code INO
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Product | Lift Chairs. Electric Positioning Chair. |
Code Information |
Model Numbers: C20, C30, GL358S, GL358L, TMR58, TMR540, TMR560, TMR570T, TMR571, TMR585, DMR670, TMR805, and TMR450. |
Recalling Firm/ Manufacturer |
Pride Mobility Products Corp 182 Susquehanna Avenue Exeter PA 18643
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For Additional Information Contact | Michael Zablocky 570-655-5574 Ext. 1410 |
Manufacturer Reason for Recall | The heating pad on these Lift Chairs may tear at the entry point causing a short and/or overheating, which can damage the chair. |
FDA Determined Cause 2 | Other |
Action | The recalling firm sent a Safety Alert notification to their direct accounts on 5/14/04 informing them of the problem. The direct accounts were instructed to locate the end user and inform them of the problem. Once the chair has been located the direct account is to contact the recalling firm for a replacement and return the recalled chair. |
Quantity in Commerce | 532 units |
Distribution | The recalled product was distributed through dealers nationwide. The affected states are as follows: AL, AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, OH, OK, MA, MD, MI, MN, MO,MS, NC, ND, NE, NH, NJ, NM, NV, NY, PA, SC, TN, TX, UT, VA, VT, WA, and WV . There is one government account in FL. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = INO 510(K)s with Product Code = INO
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