Device recall: 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer. Product Usage…
Class II FDA enforcement event 77560. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
The connection between the Female Luer and the NanoClave manifold has the potential for developing a leak.
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
ICU Medical, Inc. started this device recall on 30 May 2017. The firm address in the FDA record is in San Clemente, CA. FDA put the recall in Class II. FDA event 77560 has 9 product records. The first FDA enforcement report date is 19 Jul 2017. The record gives the status Terminated, with the termination date 20 Sep 2024.
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.
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
Recalling firm
ICU Medical, Inc., San Clemente, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
9 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2716-2017 | 18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle… | 304 units | Class II | Terminated | 19 Jul 2017 |
| Z-2717-2017 | 168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient’s vascular system through the… | 120 units | Class II | Terminated | 19 Jul 2017 |
| Z-2718-2017 | 28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave Manifold, Check Valve, 2 NanoClave, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle… | 50 units | Class II | Terminated | 19 Jul 2017 |
| Z-2719-2017 | 28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s… | 6 units | Class II | Terminated | 19 Jul 2017 |
| Z-2720-2017 | PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, NanoClave (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient’s vascular system through the… | 70 units | Class II | Terminated | 19 Jul 2017 |
| Z-2721-2017 | Kit w/3 Ext Sets, 3 Drop-In MicroClave Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle or catheter (which is inserted into a vein). | 100 units | Class II | Terminated | 19 Jul 2017 |
| Z-2722-2017 | 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient’s vascular system through the… | 900 units | Class II | Terminated | 19 Jul 2017 |
| Z-2723-2017 | 10" Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient’s vascular system through the administration set’s needle or catheter… | 1,100 units | Class II | Terminated | 19 Jul 2017 |
| Z-2724-2017 | 10" Smallbore Ext Set w/6-Port NanoClave Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient’s vascular… | 100 units | Class II | Terminated | 19 Jul 2017 |
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 2017
- 1,091
- Share of these events in Class II
- 93%
- Product records in this event
- 9Median of the firm: 2
- Events of the firm on the register
- 75
Other events of the firm
Official channels
- FDA enforcement report Z-2716-2017The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 77560. https://recallregister.com/fda/ii/77560/. 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:
Distribution to Italy and France, and the following states in the US: AZ, OH, TX, WA.
- What quantity of product is in FDA event 77560?
- The event has 9 product records. The first record gives this quantity:
304 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2017 have the same class?
- 93% of the 1,091 device events that started in 2017 are in Class II.