Device recall: MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector
Class II FDA enforcement event 95615. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
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
MEDLINE INDUSTRIES, LP - Northfield started this device recall on 16 Oct 2024. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 95615 has 8 product records. The first FDA enforcement report date is 4 Dec 2024. 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.
US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
8 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0508-2025 | MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector | 1975 units | Class II | Ongoing | 4 Dec 2024 |
| Z-0509-2025 | MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORAL BLOCK TRAY, REF DYNJRA1739B; 5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1869; 6) CONT EPID 18G NDL/20G CATH, REF… | Class II | Ongoing | 4 Dec 2024 | |
| Z-0510-2025 | MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20 | 5975 units | Class II | Ongoing | 4 Dec 2024 |
| Z-0511-2025 | MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A | 3396 units | Class II | Ongoing | 4 Dec 2024 |
| Z-0512-2025 | MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644 | 3006 units | Class II | Ongoing | 4 Dec 2024 |
| Z-0513-2025 | MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024 | 3744 units | Class II | Ongoing | 4 Dec 2024 |
| Z-0514-2025 | MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A | 360 units | Class II | Ongoing | 4 Dec 2024 |
| Z-0515-2025 | MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A | 2592 units | Class II | Ongoing | 4 Dec 2024 |
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 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 8Median of the firm: 2
- Events of the firm on the register
- 120
Other events of the firm
Official channels
- FDA enforcement report Z-0508-2025The 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 95615. https://recallregister.com/fda/ii/95615/. 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:
US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
- What quantity of product is in FDA event 95615?
- The event has 8 product records. The first record gives this quantity:
1975 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.