Recall Z-1256-2023 ยท FPO Stretcher, Wheeled
Stryker Medical Division of Stryker Corporation
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
| Date | Mar 15, 2023 (initiated Feb 1, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by 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 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 cop |
| Quantity | 4 units |
| Distribution | US Nationwide distribution in the states of NY, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.