Device recall: Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic…
Class II FDA enforcement event 78483. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
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
Owen Mumford USA, Inc. started this device recall on 6 Nov 2017. The firm address in the FDA record is in Marietta, GA. FDA put the recall in Class II. FDA event 78483 has 2 product records. The first FDA enforcement report date is 24 Jan 2018. The record gives the status Terminated, with the termination date 12 Feb 2021.
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 Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV
Recalling firm
Owen Mumford USA, Inc., Marietta, GA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0381-2018 | Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. | 2,660 cartons (266,000 pen needles) | Class II | Terminated | 24 Jan 2018 |
| Z-0382-2018 | Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors. | 708 cartons (21,240 pen needles) | Class II | Terminated | 24 Jan 2018 |
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
- 2Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 May 2021 | Unifine Pentips Plus, hypodermic needle - Product Usage: Pen needles with built in pen needle remover. | Device | Class II | 1 |
| 17 Jul 2019 | Autoject EI, REF AJ1310 | Device | Class II | 2 |
| 11 Dec 2014 | Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01, The produ | Device | Class II | 1 |
| 24 Nov 2014 | Autoject E1 Fixed needle device, Model Number AJ1310, UPC Code 384701310010 The Autoject E1 is an injector used by patie | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0381-2018The 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 78483. https://recallregister.com/fda/ii/78483/. 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 Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV
- What quantity of product is in FDA event 78483?
- The event has 2 product records. The first record gives this quantity:
2,660 cartons (266,000 pen needles)
- 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.