ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
FDA Recall #Z-0429-2024 — Class II — August 30, 2023
Product Description
ProCuity bed series, model number 3009, item number: 3009PX-LEX-400.
Reason for Recall
Patient beds are missing test values for electrical safety tests presenting risk of tissue burn or electrical shock.
Recalling Firm
Stryker Medical Division of Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
Distribution US Nationwide including Puerto Rico, Australia, Canada, Chile, China, Mexico, Poland, Spain and Switzerland.
Code Information
UDI-DI (GTIN): 07613327541229. Serial numbers: 2203001674, 2203001673, 2203001662, 2203001328, 2112001472, 2201001284, 2201001262, 2201001258, 2210002490 , 2210002246 , 2203001157 , 2210000264 , 2108002021 , 2207000782 , 2207000778 , 2208000442 , 2107000549 , 2103001807 , 2107000349 , 2206000057 , 2206000027 , 2206000007 , 2206000001 , 2105001397 , 2105001386 , 2202000874 , 2202000831 , 2203002026 , 2203001847 , 2105001777 , 2105001733 , 2105001730 , 2105001704 , 2105001694 , 2212001339, 2212001353, 2212001354, 2212001371 , 2209001039 , 2107000414 , 2104003152 , 2106002729 , 2106002525 , 2210002613 , 2210002592 , 2209001197 , 2212001462, 2209000157 , 2209000148 , 2209000132 , 2209000131 , 2209000129 , 2209000124 , 2208002626 , 2208002260 , 2208002189 , 2208002119 , 2208002117 , 2109001048 , 2102003094 , 2101002546 , 2101002504 , 2110000684 , 2203000449 , 2203000444 , 2202000882 , 2212000954 , 2212000966 , 2212000971 , 2212000987 , 2212000995 , 2212001051 , 2212001056 , 2212001072 , 2209001661 , 2212000653, 2212000632 , 2212000137 , 2212000053 , 2110001030 , 2202000968 , 2210002107 , 2210002092 , 2210002090 , 2102002723 , 2102002735 , 2210002089 , 2210002086 , 2210002064 , 2210001780 , 2102002782 , 2102001851 , 2210001325 , 2210001382 , 2210001395 , 2211000549 , 2211003332 , 2211000994 , 2211000932 , 2111001755 , 2111001751 , 2209000399 , 2206000124 , 2206000106 , 2104003071 , 2111000703 , 2111001128 , 2111000790 , 2111000789 , 2012000962 , 2011000951 , 2011000882 , 2109002087 , 2109002064 , 2109002045 , 2011002330 , 2112001153 , 2112001143
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.