Recall Z-0326-2017— Hill-Rom, Inc.
Class II · Terminated
Class II FDA medical device recall by Hill-Rom, Inc., initiated 2016-08-09, terminated 2017-03-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.. Reason: Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling Ultra System installation with the M8 screw and the safe working load is exceeded, the system could fall..
- Recalling firm
- Hill-Rom, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-09
- Terminated
- 2017-03-24
- Firm location
- Batesville, IN, United States
Product description
Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling installed rail systems: Multirall 200, Likorall 200, 242, 243, 250, and LikoGuard L and XL.
Reason for recall
Ceiling Bracket 71 was shipped with a larger center hole. A potentially hazardous situation exists that if the Ceiling Bracket 71 with a larger center hole is used for a concrete ceiling Ultra System installation with the M8 screw and the safe working load is exceeded, the system could fall.
Data sourced from openFDA. This site is unofficial and independent of the FDA.