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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Secure Care Bed (Model 3221

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  Class 2 Device Recall Stryker Secure Care Bed (Model 3221 see related information
Date Initiated by Firm March 12, 2012
Date Posted March 30, 2012
Recall Status1 Terminated 3 on August 29, 2013
Recall Number Z-1356-2012
Recall Event ID 61054
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product Stryker Secure Model 3221, 230 V- 50/60 Hz, 500 lbs (227 Kg)
Stryker, Kalamazoo, MI 49001

Product Usage:
Secure II (model 3221) Med/Surg beds are AlC powered hospital beds, intended for clinician use, which consist of built-in motors and remote controls that can be operated by the patient and/or clinician to adjust the height and surface contour of the beds. The Secure II model is primarily used in the Med/Surg units, but may also be found in a Critical Care environment. . Models 3221 represents International Voltage configurations of the 3002 model.
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Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 East Centre Ave.
Portage MI 49002
For Additional Information Contact Renata Sila
269-324-6609
Manufacturer Reason
for Recall		 Stryker Medical has determined that units manufactured between September 1, 2004 through November 30, 2007, did not receive updated preventive maintenance information. (Failure to maintain the bed brakes including the brake plate kits, may result in reduced brake holding force. Reduced braking force may result in a patient fall or caregiver muscle strain, either of which may require medical int
FDA Determined
Cause 2		 Component change control
Action Stryker Medical sent an Urgent-Medical Device Correction letter dated March 12, 2012 to all consignees. The letter identified the affected products, problem, updated preventive maintenance information and requested the following immediate actions: 1) Locate the beds listed in this notice, 2) Ensure that the brakes are holding properly, 3) If the brakes are not holding, contact Stryker (1-800-327-0770, option 4) to order the maintenance parts, 3) Continue to periodically inspect brake functionality, as noted on enclosed preventive maintenance schedule/checklist, 4) Order replacement brake components, as needed, 5) Return the enclosed post card to confirm receipt of this notification, 6) If you have loaned or sold any of the beds listed in this letter, please, forward a copy of this notice to the new users and advise us of their new location, 6) If you have disposed of any of the beds and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. For questions or concerns, please, contact Sandy Cliche at 269-389-6025.
Quantity in Commerce 467
Distribution Worldwide Distribution - USA (nationwide) including the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and the countries of: DEDEDO GU, HAMILTON ON, SANTIAGO, SHATIN, NT , CAPITOL FEDERAL, ITAPEVI SP, ATHENS, OSAKA, SEOUL, MEXICO DF MX, MONTREUX, BALERNA, NORTH POINT, WARSZAWA, CANOVANAS, KOWLOON BAY, SINGAPORE, NEWBURY, and JOHANNESBURG.
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.
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