Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0727-2007

Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift) Sunrise Medical, Inc

Joerns Healthcare / initiated 2007-02-21 / Terminated / root cause: supplier

Joerns Healthcare Inc. began a recall of Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift) Sunrise Medical, Inc on . The reason FDA records is "Unapproved Design Change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds)". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number
Z-0727-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Joerns Healthcare
Product
Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift) Sunrise Medical, Inc.
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
Unapproved Design Change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds).
Root cause tag
supplier
FDA root cause
Other
Action
Recall initiated by letter dated 2/21/2007. Sunrise Medical will schedule onsite appointments to complete the base replacement.
Quantity in commerce
581 units
Distribution
Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and country of Canada.
Product codes and lots
1)-Model Number : Hoy - Advance - E with Serial numbers: 0601L0433 through 0601L0441, 0603L0294 through 0603L0336, 0603L0493 through 0603L0501, 0603L1011 through 0603L1021, 0603L1139 through 0603L1187, 0603L1285 through 0603L1294, 0604L0394 through 0604L0411, 0604L0885 through 0604L0941, 0604L1002 through 0604L1012, 0606L0365 through 0606L0431, 0606L0789 through 0606L0818, 0606L1006 through 0606L1030, and 0607L0001 through 0607L0090--2)Model Number: Hoy - Advance - H with Serial numbers: 0601L0442 through 0601L0459, 0603L0286 through 0603L0293, 0603L1022 through 0603L1041, 0603L1295 through 0603L1330, 0603L1519 through 0603L1572, 0605L0742 through 0605L0753, 0606L0049 through 0606L0142, 0606L0819 through 0606L0848, and 0606L1031 through 0606L1144