Z-2146-2026Class I
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-03-24 / Open, Classified
Medline Industries, LP began a recall of Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B on . FDA classified it as Class I and gives the reason as "Medline has identified the presence of particulate within the fluid path of the Manifolds". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-2146-2026
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH PACK-LF, Medline Kit Number/SKU DYNJ36478B
- Product code
- OGR Ear, Nose, And Throat Surgical Tray
- Reason for recall
- Medline has identified the presence of particulate within the fluid path of the Manifolds.
- FDA root cause
- Under Investigation by firm
- Action
- Medline Industries, LP issued an URGENT MEDICAL DEVICE notice to its consignees on 3/24/2026 via email and mail. The notice explained the issue, potential risk and requested the following: "REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-046 Recall Code: 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product." For questions, contact the Recall Department at 866-359-1704 or [email protected].
- Quantity in commerce
- 0 kits
- Distribution
- US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.
- Product codes and lots
- UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 26CMC977
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2138-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2139-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2140-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2141-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2142-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2143-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2144-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2145-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2146-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2147-2026 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-2148-2026 | Class I | Ongoing | Voluntary: Firm initiated |
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