CLASS II Device recall · Reported 13 Jan 2021 · FDA Enforcement Report
MiniCap Extended Life PD Transfer Set recalled by Baxter Healthcare
Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Set, distributed nationwide in the US. The recall was initiated on 10 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0768-2021
- FDA event ID
- 86883
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Nov 2020
- FDA classified
- 4 Jan 2021
- Reported
- 13 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 10 Nov 2020 | Recall initiated by company | |
| 4 Jan 2021 | Classified by FDA | +55 days |
| 13 Jan 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for no-flow and leaks under the twist clamp.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
MiniCap Extended Life PD Transfer Set
Where it was distributed
Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia
Questions about this recall
Why was it recalled?
Potential for no-flow and leaks under the twist clamp.
Which lots are affected?
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
Where was it sold?
Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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