Stryker Medical Division of Stryker Corporation: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals

Agency Publication Date: August 6, 2021

Affected Products

Product: ComfortGel - assists in the prevention and treatment of all pressure injury stages, Model Number 2850, Part # 2850000999, 2850000001, 2850000009

Serial Numbers: 20170928500311838 UDI: 07613327277852 07613327277937

Product: IsoGel Air - support surface assists in the prevention and treatment of all pressure ulcers stages, Model Number 2860, Part 2860000999

Serial Numbers: 031528600216109 051428600212599 081328600206460 UDI: 07613327298512

Product: Transport Stretcher 747 - a non-powered, wheeled device designed to support patients in a horizontal position, Part Number 0747000000

UDI (DI#): 07613327278187

Product: Surgistool-intended to support a healthcare professional during surgical procedures Model 830, Part Number 0830000000

Serial Numbers: 1202033898 1206032470 1406034563 1607037109 UDI (DI#): 07613327282566

Product: Prime Fifth Wheel Stretcher-stretcher may be used for minor procedures and short-term stay (treatment and recovery, Model 1105, Part Numbers 1105000026 and 1105000000X

UDI (DI#) 07613327278149 07613327278149 07613327278194

Product: Prime Big Wheel Stretcher-used as a short-term outpatient clinical evaluation, treatment, minor procedure, and short-term outpatient recovery platform, Model Number 1115, Part Number 1115000030

UDI (DI#): 07613327278330

Product: Prime TC-transport chair intended for medical purposes to assist a person in performing an activity that the person would find difficult to do or be unable to do Model Number: 1460, Part #1460000000¿¿¿¿¿¿¿

Serial Numbers: 1911040132 1911040133 UDI: 07613327282665

Product: InTouch 2131-intended to support a human patient in an acute care setting, Model Number: 2131000000, Part #1460000000¿¿¿¿¿¿¿

Serial Numbers: U54274 U71491 UDI:07613327169294

Product: Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿

Serial Numbers: 111427102713678 UDI:N/A

Product: S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number 3002, Part 3002S3CUSTOM, 3002S3EX, 3002S3PATRIOT

Serial Numbers: 110715076 110915596 110915597 111015378 111015411 110515348 110515556 110517101 110915707 110915708 110915743 111118747 111215214 111216659 111216660 111216671 110717082 110717084 140915228 150615371 100215401 UDI: 07613327278408

Product: Isolibrium Support Surface - support surface assists in the prevention and treatment of all pressure injury stages (including stages 1, 2, 3, 4, Unstageable and Deep Tissue Pressure Injury, Model Number: 2972, Part # 2972000000

Serial Numbers: 219009000417 UDI: 07613327278453

Product: S3 MedSurg Bed - intended to support and transport patients within the Med/Surg and Critical Care hospital environments, Model Number: 3005, Part # 3005S3EX

Serial Numbers: 120916611 121016000 130115957 130815166 UDI: 07613327278309

Product: TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, supine, and trend positions, Model Number: 3333, Part #¿3333000000

Serial Numbers: 2017000300284 UDI: 07613327322569

Product: Symmetry Plus Treatment Recliner - general hospital use as a convenient seating surface for patients or guests to sit, Model Number 3500, Part # 3500000710

Serial Numbers: G201170298 G201181816 G201318385 UDI: 07613327282436

Product: Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000 ¿

Serial Numbers: G201179538 UDI: 07613327506129

Product: Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050¿¿¿¿ Part # 5050000000

Serial Numbers: N/A UDI: 07613327282511

Product: CUB Pediatric Crib- intended to provide a pediatric patient support surface for medical purposes and to provide a method of transporting pediatric patients within a healthcare facility Model Number: FL19 Part #5050000000

Serial Numbers: F09519 F50699 UDI:07613327169348

Product: Electric MedSurg Bed FL23 - AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes, Model Number: FL23, Part #FL23SE

Serial Numbers: FL23J50576 FL23J50577 FL23J60424 FL23J60627 J32346 J32347 J32348 J32350 J29770 UDI: N/A

Product: GoBed II MedSurg Bed, Model Number FL28, Part #FL28EX

Serial Numbers: R52495 R53376 R55047 R56034 M14805 M14885 M14886 M14931 M14936 M14938 M14939 M50074 M50425 M50951 M50956 M54387 R63407 R54523 R54610 R54696 R54698 R60775 R32649 R25384 R35631 R35734 R58735 M15330 R58474 UDI: 07613327169355 07613327169386

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88199

Status: Active

Manufacturer: Stryker Medical Division of Stryker Corporation

Manufactured In: United States

Units Affected: 19 products (3 units; 4 units; 3 units; 1 unit; 2 units; 2 units; 1 unit; 3 units; 3 units; 21 units; 1 unit; 4 units; 1 unit; 3 units; 1 unit; 1 unit; 2 units; 9 units; 33 units)

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Sources: FDA iRES · Raw API Response

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