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Open, Classified

Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001

FDA Recall Z-1256-2023 · Posted 2023-03-15

Recall StatusOpen, Classified
Product CodeFPO
Date Initiated2023-02-01
Product Quantity4 units

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.

Firm Action

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 [email protected]. 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

Distribution Pattern

US Nationwide distribution in the states of NY, VA.

Official Source

View FDA Recall →

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

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