Z-0742-2018 Class II Terminated
FDA device recall Z-0742-2018 was initiated by Angiodynamics, Inc. on September 22, 2017 and is designated Class II. Reason for recall: Product was placed into distribution prior to completion of all required post sterilization release activities. The recall status is terminated (terminated September 19, 2018). Affected quantity: 28.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- September 22, 2017
- Termination Date
- September 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28
Product Description
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
Reason for Recall
Product was placed into distribution prior to completion of all required post sterilization release activities.
Distribution Pattern
US Distribution to the states of : AL, CA, CT, FL, GA, IL, IN, MD, MI, MN, MO, OH, OR, TX.
Code Information
Lot Number: 5229642; Manufactured 6-Sep-17; Expiration Date: 31-Aug-20