| Class 2 Device Recall "Shower Helper" and "Bath Helper" | |
Date Initiated by Firm | June 01, 2007 |
Date Posted | August 17, 2007 |
Recall Status1 |
Terminated 3 on August 19, 2008 |
Recall Number | Z-1172-2007 |
Recall Event ID |
38096 |
Product Classification |
Patient Lifts - Product Code FSA
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Product | Non-AC-powererd Patient Lifts for assisting patients when bathing and toileting-sold under names "Bath Helper" and "Shower Helper" , Sisus Corporation, Santa Cruz, CA 95062. |
Code Information |
The "Shower Helper" may be identified as Model SBH10.0 or as "Sisus All In One". The "Bath Helper" is identified as Model SBB10.0. |
Recalling Firm/ Manufacturer |
The Sisus Corporation 721 30th Ave Santa Cruz CA 95062-5070
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For Additional Information Contact | Simon Kaiwai 415-235-0558 |
Manufacturer Reason for Recall | Poor welding may cause the device(s) to fail, which may result in the user, falling in the bathroom and/or a lack of assistance with bathing or toileting. |
FDA Determined Cause 2 | Device Design |
Action | On 6/8/2007, a letter was sent to all dealers and each direct account customer/user followed by a phone call to ensure the notification letter was received. Customers were instructed to discontinue use of the devices pending receipt of modification kits/ instructions to be shipped priority overnight. The firm plans to call customers/dealers to support them with the installations and ensure smooth implementation. Dealers were instructed to conduct recall to the user level. |
Quantity in Commerce | approximately 100 units have been distributed. |
Distribution | Nationwide Distribution including states of PA, TX, NY, MI, AL, FL, CA, OH, CT, WA, MD, OR, NC, NH, VT, IL, CO, HI, LA, GA, TN, OK, MA, KS, SC, ME, GA, MN, IN, and DE. |
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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