Slany, N/A, Czech Republic
Linet Spol. S.r.o. recalls
3 recalls recorded since 2018, most recently on 18 January 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 January 2023
- Reason
- Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury.
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1211-2023
- Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
Ongoing Class II Medical devices
- Recall started
- 13 November 2019
- Reason
- A component used within the side rail mechanism may malfunction, resulting in the side rail either not locking properly in the upper position or the side rail becoming stuck in the upper position.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0767-2021
- Eleganza 5 (AC powered adjustable bed), Item Numbers: a) 1GE512055-40, b) 1GE512055-45, c) 1GE512055-85, and d) 1GE512055-95 - Product Usage: Eleganza 5 is a positionable bed for intensive care. Its purpose is to suppor
Terminated Class II Medical devices
- Recall started
- 7 January 2019
- Terminated
- 31 May 2023
- Reason
- LINET has recently become aware of a potential safety issue for the AVE 2 Birthing Bed caused by the power cable breaking at the bed connection or the orange insulation of the power cable may fail causing a possible spark or possible exposure to a live conductor.
- Distribution
- AL, OK, NJ, OR, WA, CA, MN, LA, AZ, IL, MO, CO, OH, KY, FL, KS, UT, TN, LA, DE, CT, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0991-2019
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.