Device recall: Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449
Class II FDA enforcement event 89327. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Baxter Healthcare Corporation started this device recall on 7 Jan 2022. The firm address in the FDA record is in Deerfield, IL. FDA put the recall in Class II. FDA event 89327 has 11 product records. The first FDA enforcement report date is 16 Feb 2022. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide
Recalling firm
Baxter Healthcare Corporation, Deerfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0570-2022 | Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449 | 23,940 units | Class II | Ongoing | 16 Feb 2022 |
| Z-0571-2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482 | 2,553,528 units | Class II | Ongoing | 16 Feb 2022 |
| Z-0572-2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483 | 344,190 units | Class II | Ongoing | 16 Feb 2022 |
| Z-0573-2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ | 61,290 units | Class II | Ongoing | 16 Feb 2022 |
| Z-0574-2022 | Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S | 116,628 units | Class II | Ongoing | 16 Feb 2022 |
| Z-0575-2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482 | 449,676 units | Class II | Ongoing | 16 Feb 2022 |
| Z-0576-2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E | 62,712 units | Class II | Ongoing | 16 Feb 2022 |
| Z-0577-2022 | Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483 | 58,194 units | Class II | Ongoing | 16 Feb 2022 |
| Z-0578-2022 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484 | 13,590 units | Class II | Ongoing | 16 Feb 2022 |
| Z-0579-2022 | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482 | 8,928 units | Class II | Ongoing | 16 Feb 2022 |
| Z-0580-2022 | Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484 | 2,240 units | Class II | Ongoing | 16 Feb 2022 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 11Median of the firm: 1
- Events of the firm on the register
- 193
Other events of the firm
Official channels
- FDA enforcement report Z-0570-2022The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 89327. https://recallregister.com/fda/ii/89327/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide
- What quantity of product is in FDA event 89327?
- The event has 11 product records. The first record gives this quantity:
23,940 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.