There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
Reason for recall: There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach. Distribution: Distribution was made nationwide. There was also government/military distribution. Foreign distribution was made to Australia, Canada, China, Japan, Qatar, Saudi Arabia, Singapore, Taiwan, Turkey, and United Arab Emirates. Quantity: 38,136 mattress units and 20,187 service part units Lot/code info: 1. REF P7922A01 - UDI-DI 887761999084; 2. REF P7922A02 - UDI-DI 887761999077; 3. REF P7922A03 - UDI-DI 887761984639; 4. REF P7922ARENT01 - UDI-DI 887761976962; 5. REF P7923A01 - UDI-DI 887761977945; 6. REF P7923A02 UDI-DI 887761977938; 7. REF P7923A03 UDI-DI 887761977921; 8. REF P7923A04 UDI-DI 887761977914; 9. REF P006800A01 - UDI-DI 887761977846; 10. REF P006800A03 - UDI-DI 887761955035; 11. REF P3255A01 - UDI-DI 887761977860; 12. REF P3255A02 UDI-DI 887761977853; 13. REF P3255ARENT01 UDI-DI 887761976887; 14. REF P7924A01 -UDI-DI 887761977907; 15. REF P7924A02 - UDI-DI 887761977891; 16. REF P7924A03 - UDI-DI 887761977884; 17. REF P7924A04 - UDI-DI 887761977877; 18. REF P7924ARENT01 - UDI-DI 887761976863.
887761999084, 887761999077, 887761984639, 887761976962, 887761977945, 887761977938, 887761977921, 887761977914, 887761977846, 887761955035, 887761977860, 887761977853, 887761976887, 887761977907, 887761977891, 887761977884, 887761977877, 887761976863
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.