Device recall: FREESTYLE LANCETS 28G 100CT Item Number:2975670
Class II FDA enforcement event 87787. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Due to shipping delays the devices were exposed to temperature excursions of 31.9°F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
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
Cardinal Health Inc. started this device recall on 16 Mar 2021. The firm address in the FDA record is in Dublin, OH. FDA put the recall in Class II. FDA event 87787 has 14 product records. The first FDA enforcement report date is 30 Jun 2021. 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 distribution in the states of FL, GA, SC.
Recalling firm
Cardinal Health Inc., Dublin, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
14 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1929-2021 | FREESTYLE LANCETS 28G 100CT Item Number:2975670 | 377 boxes of 100 lancets | Class II | Ongoing | 30 Jun 2021 |
| Z-1930-2021 | FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084 | 8,959 kits | Class II | Ongoing | 30 Jun 2021 |
| Z-1931-2021 | FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877 | 2,115 kits | Class II | Ongoing | 30 Jun 2021 |
| Z-1932-2021 | AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033 | 100 units | Class II | Ongoing | 30 Jun 2021 |
| Z-1933-2021 | BD UF PEN 32GX4MM 100 NANO Item Number: 4292272 | 1,599 boxes of 100 needles | Class II | Ongoing | 30 Jun 2021 |
| Z-1934-2021 | DEXCOM G6 SENSOR 3 PACK Item Number: 5447552 | 2357 kits | Class II | Ongoing | 30 Jun 2021 |
| Z-1935-2021 | VAPORIZER VICKS 1.5GAL Item Number: 2354942 | 1 unit | Class II | Ongoing | 30 Jun 2021 |
| Z-1936-2021 | ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174 | 5,356 boxes of 100 strips | Class II | Ongoing | 30 Jun 2021 |
| Z-1937-2021 | ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788 | 531 boxes of 100 lancets | Class II | Ongoing | 30 Jun 2021 |
| Z-1938-2021 | ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443 | 144 boxes of 25 strips | Class II | Ongoing | 30 Jun 2021 |
| Z-1939-2021 | ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610 | 2,315 boxes of 100 lancets | Class II | Ongoing | 30 Jun 2021 |
| Z-1940-2021 | ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628 | 4,896 boxes of 100 lancets | Class II | Ongoing | 30 Jun 2021 |
| Z-1941-2021 | OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326 | 375 units | Class II | Ongoing | 30 Jun 2021 |
| Z-1942-2021 | ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862 | 537 boxes of 100 strips | Class II | Ongoing | 30 Jun 2021 |
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 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 14Median of the firm: 3
- Events of the firm on the register
- 12
Other events of the firm
Official channels
- FDA enforcement report Z-1929-2021The 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 87787. https://recallregister.com/fda/ii/87787/. 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 FL, GA, SC.
- What quantity of product is in FDA event 87787?
- The event has 14 product records. The first record gives this quantity:
377 boxes of 100 lancets
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.