Z-1621-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2023
- Initiation Date
- April 24, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 kits
Product Description
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Reason for Recall
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Distribution Pattern
US: MA OUS: None
Code Information
Lot 188843; UDI: B098AMS4601E0