Recall Z-1211-2023 ยท FPO Stretcher, Wheeled
Linet Spol. S.r.o.
Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
| Date | Mar 4, 2023 (initiated Jan 18, 2023) |
| Status | Open, Classified |
| Reason | Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury. |
| Root cause | Labeling design |
| Action | The firm issued "URGENT MEDICAL DEVICE CORRECTION" recall letters dated 1/17/2023 via email on 1/18/2023. The letter explains the issue that an audible clicking sound can be heard when the side rail is raised, but this sound does not indicate the side rail has locked into the raised position. The consignee is to take immediate action to notify caregivers using the Sprint 200 of this potential hazard and proper use for securing a side rail in the raised position. The consignee is informed that Linet will be adding additional safety warning labels located at each side rail latch (2 per side |
| Quantity | 335 stretchers (310 US, 25 OUS) |
| Distribution | US Distribution was made to AL, CA, FL, IA, KY, LA, MN, NV, NC, OK, TX, VA, WA, and WV. There was no government/military distribution. Foreign distribution was made to Australia, Bahrain, Belgium, Germany, Great Britain, Italy, Netherland, Singapore, South Africa, Switzerland, and United Emirates |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.