Z-2496-2019 Class II Terminated
FDA device recall Z-2496-2019 was initiated by Aesculap Implant Systems LLC on August 7, 2019 and is designated Class II. Reason for recall: possibility of the sterility batch being insufficiently sterilized The recall status is terminated (terminated May 12, 2020). Affected quantity: 3 unit of Lot 837B.
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2019
- Initiation Date
- August 7, 2019
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 unit of Lot 837B
Product Description
CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrument intended for use in general surgery and gynecologic procedures where ligation and division of vessels is desired.
Reason for Recall
possibility of the sterility batch being insufficiently sterilized
Distribution Pattern
US Nationwide distribution in the state of CA.
Code Information
Lot # 109C and 837B