Z-0768-2021 Class II Terminated
FDA device recall Z-0768-2021 was initiated by Baxter Healthcare Corporation on Nov 10, 2020 and is designated Class II. Reason for recall: Potential for no-flow and leaks under the twist clamp. The recall status is terminated (terminated Mar 24, 2023). Affected quantity: 72,771 units.
Recall details
- Product Type
- Devices
- Report Date
- Jan 13, 2021
- Initiation Date
- Nov 10, 2020
- Termination Date
- Mar 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 72,771 units
Product description
MiniCap Extended Life PD Transfer Set
Reason for recall
Potential for no-flow and leaks under the twist clamp.
Distribution pattern
Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia
Code information
Product Code: 5C4482, UDI: 00085412007731, Lot#, Expiration Date: H20D13100, 4/13/2025; H20D27084, 4/27/2025; H20D30070, 4/30/2025; H20E13107, 5/13/2025; H20E19054, 5/19/2025; H20E22082, 5/22/2025; H20F09061, 6/9/2025; H20F15050, 6/15/2025; H20F18070, 6/18/2025; H20F24086, 6/24/2025; H20F29051, 6/29/2025; H20G13046, 7/13/2025; H20G27087, 7/27/2025; H20G30065, 7/30/2025; H20H05057, 8/5/2025; H20H14067, 8/14/2025; H20H19066, 8/19/2025
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0768-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026