CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7 recallZ-1048-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Dec 23, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
FDA root cause category: Process change control
What the company is doing
Medline Industries, LP issued one IMMEDIATE ACTION REQUIRED notice and one MEDICAL DEVICE RECALL notice to its affected consignees on 12/23/2024 via email and US Mail. The IMMEDIATE ACTION REQUIRED notice explained the labeling issue with the device, potential risk, and requested the following actions be taken: 1. affected catheters be quarantined, 2. respond with quantity on hand, 3. if the product was transferred to notify those to whom the affected catheters were transferred. Upon receipt of the response. Medline will issue corrected labeling to affix to the devices. The MEDICAL DEVICE RECALL notice, which pertains to kits manufactured with the affected catheters as a component, also explained the labeling issue with the device, potential risk, and requested the following actions be taken: 1. affected catheters be quarantined, 2. respond with quantity on hand, 3. if the product was transferred to notify those to whom the affected catheters were transferred. Upon receipt of the response. Medline will issue a label to affix to the devices which will state the affected component shall be removed and discarded from further use.
Recall details
- Recall number
- Z-1048-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 23, 2024
- Posted by the FDA
- Jan 29, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 1200 units
- Product code
- DYB
- FDA submissions
- K885179
- Distribution
- US: FL, KS, ND, PA, WA, WV, IL, WA
Product description
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
Code information (models, lots, serial numbers)
UDI/DI 10653160249979 (EA) 20653160249976 (CS), Lot Numbers: 2024103190, 2024050990, 2024021290, 2024012990, 2024111990
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Centurion MIC17F7Centurion Medical Products Corporation · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96066).
- Z-1049-2025 · Open, ClassifiedMEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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