Z-1329-2021 Class II Terminated
FDA device recall Z-1329-2021 was initiated by Oscor, Inc. on Mar 10, 2021 and is designated Class II. Reason for recall: Potential for open seal on sterile product The recall status is terminated (terminated Aug 8, 2023). Affected quantity: 500 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 7, 2021
- Initiation Date
- Mar 10, 2021
- Termination Date
- Aug 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 500 devices
Product Description
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Reason for Recall
Potential for open seal on sterile product
Distribution Pattern
US Nationwide distribution in the state of New York.
Code Information
GUDID: 25051684026298; Lot Number DP-11759
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1329-2021
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026