Z-2051-2021 Class II Terminated
FDA device recall Z-2051-2021 was initiated by Baxter Healthcare Corporation on Jun 15, 2021 and is designated Class II. Reason for recall: There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date The recall status is terminated (terminated Jan 12, 2024). Affected quantity: 4,752 units.
Recall details
- Product Type
- Devices
- Report Date
- Jul 21, 2021
- Initiation Date
- Jun 15, 2021
- Termination Date
- Jan 12, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,752 units
Product description
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
Reason for recall
There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date
Distribution pattern
United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom.
Code information
Product Code: ADS201897. Lot Numbers: 0000266641, 0000325839, 0000362640, 0000380266.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2051-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026