CLASS II ONGOING Device recall · Reported 15 Mar 2023 · FDA Enforcement Report
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P recalled
Baxter Healthcare is recalling Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P, distributed nationwide in the US. The recall was initiated on 1 Feb 2023 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-1213-2023
- FDA event ID
- 91612
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Feb 2023
- FDA classified
- 3 Mar 2023
- Reported
- 15 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Infusion Pumps
Timeline
| 1 Feb 2023 | Recall initiated by company | |
| 3 Mar 2023 | Classified by FDA | +30 days |
| 15 Mar 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for peritoneal dialysis
Where it was distributed
US Nationwide distribution and Canada.
Stores named: Walmart
Questions about this recall
Is Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P recalled?
Yes. Baxter Healthcare recalled Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P on 1 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1213-2023.
Why was it recalled?
MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals. This could lead to exposure to air, resulting in insufficient iodine/dry sponge inside the MiniCap, which could lead to the potential for inadequate disinfectant.
Which lots are affected?
UDI/DI 00085412007694, Lot numbers: GD912051, exp 31-Mar-2024; GD912068, exp 30-Apr-2024; GD912099, exp 30-Apr-2024; GD912112, exp 30-Apr-2024; GD912143, exp 30-Apr-2024; GD912204, exp 31-May-2024. Expansion on 05/10/2023: Product Code 5C4466P with all lots numbers manufactured prior to 09/30/2022.
Where was it sold?
US Nationwide distribution and Canada.
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 21 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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