Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Mod

FDA device recall Z-1256-2023 · posted 2023-03-15 · Open, Classified

Recall details

Recalling firm

Stryker Medical Division of Stryker Corporation

Reason for recall

Transport Cot has insufficient volume of epoxy to assemblies installed in the head section and foot sectioning system may result in separation of head end or foot end from the cot and result in unexpected disengagement while loading/unloading or transport.

Action taken

Stryker issued Urgent Medical Device Correction letter dated 2/1/23. Letter states reason for recall, health risk and action to take: 1. Locate the units listed on the attached business reply form and remove them from service until repairs are complete. 2. Return the enclosed business reply form to confirm receipt of this notification by fax +1 269 488 8691 or email productfieldaction@stryker.com. 3. Stryker will contact you to arrange for the modification/repair of your Power-PRO 2. 4. If you have loaned or sold or disposed of any of the products listed in this letter, please forward a copy of this notice to the new users and advise us of their new location in the space provided on the business reply form. Questions or concerns, contact Customer Service at +1 800 327 0770 Monday through Friday from 8:00 a.m. to 6:00 p.m. ET.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FPO

Quantity affected

4 units

Distribution

US Nationwide distribution in the states of NY, VA.

Date initiated

2023-02-01

Date posted

2023-03-15

Location

Portage, MI