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Terminated

Manual Mechanical Wheelchair, 16'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold in the following configurations: reorder 16-7910: Fixed Full Arm, Swing Footrest reorder 16-7911: Fixed Full Arm, Elevating Adjustable Legrest reorder 16-7912: Removable Desk Arm, Swing Footrest reorder 16-7913: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7914: Removable Full Arm, Elevating Adjustable Legrest

FDA Recall Z-0643-05 · Posted 2005-03-22

Recalling FirmCypress Medical Products, Ltd.
Recall StatusTerminated
Product CodeIOR
Date Initiated2004-05-03
Date Terminated2005-08-19
Product Quantity3 chairs

Reason for Recall

The seat of the wheelchair may come loose from the frame with the screws and the collars still attached when the seat is pulled upward to fold the wheelchair.

Firm Action

Cypress Medical telephoned McKesson on 5/3/04, informing them of the problem with the rivet screw collar and requesting them to place the wheelchairs on hold in their distribution warehouses, pending inspection and tightening of the rivet screws to properly seat the rivet crew collar into the frame. Cypress also called all direct accounts in June and July 2004, and known end users in January 2005. Voluntary Field Correction letters dated 3/3/05 are being sent to those end users who could not be reached by telephone.

Root Cause

Other

Distribution Pattern

Nationwide through McKesson Medical-Surgical warehouses in Kansas City, MO; Suwanee, GA; Baltimore, MD; Orlando, FL; Charlotte, NC; Nashville, TN; Richmond, VA; Atlanta, GA; Little Rock, AR; Grapevine, TX; Denver, CO; Tewksbury, MA; Cheshire, CT; Grove City, OH; Rochester, NY; Eagan, MN; Tempe, AZ; Auburn, WA; Livonia, MI; and Ontario, CA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002670EZ-TRAVELER 3000 SERIES MANUAL WHEELCHAIRJiangsu Intco Medical Equipment & Supply Co., Ltd. · 2000-10-11K002671EZ-TRAVELER 2500 SERIES MANUAL WHEELCHAIRJiangsu Intco Medical Equipment & Supply Co., Ltd. · 2000-10-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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