Z-1468-2021 Class II Terminated
FDA device recall Z-1468-2021 was initiated by Trinity Sterile, Inc. on February 23, 2021 and is designated Class II. Reason for recall: Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility The recall status is terminated (terminated February 16, 2023). Affected quantity: 2970 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 28, 2021
- Initiation Date
- February 23, 2021
- Termination Date
- February 16, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2970 units
Product Description
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
Reason for Recall
Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Distribution Pattern
US Nationwide distribution in the states of IA, IL, MN, MO, MS, NE, NE, NY, OH, OK, TX, VA.
Code Information
Lot Number: 600001 UDI: (01)00841767107942(17)2022-04- 30(10)600001