Device recall: Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro Edge” Safety…
Class II FDA enforcement event 69842. Recall start date: . Status in the FDA record: Completed.
Reason for recall, in the words of FDA
Needle is not captured in the needle safety sheath in specific lots.
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
Smiths Medical ASD, Inc. started this device recall on 21 Nov 2014. The firm address in the FDA record is in Keene, NH. FDA put the recall in Class II. FDA event 69842 has 3 product records. The first FDA enforcement report date is 7 Jan 2015. The record gives the status Completed.
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 AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV
Recalling firm
Smiths Medical ASD, Inc., Keene, NH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0897-2015 | Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro Edge” Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe. | 334,000 | Class II | Completed | 7 Jan 2015 |
| Z-0898-2015 | Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro Edge” Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe. | 47,200 | Class II | Completed | 7 Jan 2015 |
| Z-0899-2015 | Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1” 5mL Luer lock syringe; Reorder Number: 452010 Product Usage: The Needle Pro Edge” Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer lock or luer slip syringe. | 10,000 | Class II | Completed | 7 Jan 2015 |
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 2014
- 1,176
- Share of these events in Class II
- 91%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 108
Other events of the firm
Official channels
- FDA enforcement report Z-0897-2015The 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 69842. https://recallregister.com/fda/ii/69842/. 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 AZ CA FL GA IL IN LA MA MN MO MS MT NC ND NJ NV NY OH OR PA RI TN TX VA WA WI WV
- What quantity of product is in FDA event 69842?
- The event has 3 product records. The first record gives this quantity:
334,000
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2014 have the same class?
- 91% of the 1,176 device events that started in 2014 are in Class II.