FDA Recall Terminated

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.

Recall: Z-1356-2012 · Initiated March 12, 2012

Recall

Recall Number
Z-1356-2012
Event Number
61054
Firm
Stryker Medical Division of Stryker Corporation
FEI Number
1831750
Product Code
FNL
Status
Terminated
Root Cause
Component change control
Initiated
March 12, 2012
Posted
March 30, 2012
Terminated
August 29, 2013
Address
3800 East Centre Ave., Portage, MI, 49002

Description

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.

Reason

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

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.

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.

Quantity

467