Z-0948-2021 Class II Terminated
FDA device recall Z-0948-2021 was initiated by Allergan PLC on Dec 29, 2020 and is designated Class II. Reason for recall: Missing Instruction For Use insert. The recall status is terminated (terminated Mar 23, 2023). Affected quantity: 24 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 10, 2021
- Initiation Date
- Dec 29, 2020
- Termination Date
- Mar 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
REFRESH CONTACTS¿ Contact Lens Comfort Drops 0.4 fl oz (12 mL) Sterile
Reason for Recall
Missing Instruction For Use insert.
Distribution Pattern
U.S.: MO O.U.S.: None
Code Information
Model Number: 91822US UDI Code: (01)00300231822120(17)230705(10)T0464A Lot Number: T0464A
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0948-2021
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026