FDA (Devices) recall action 87787
The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Cardinal Health is recalling OneTouch Delica Lancets (100-count boxes) after devices were exposed to freezing temperatures during shipping, which may affect blood glucose test accuracy. No injuries have been reported.
Cardinal Health Inc. is recalling OneTouchDelica Lancets 33G because devices were exposed to freezing temperatures (31.9°F) during shipping, which may cause inaccurate test results.
Cardinal Health is recalling FreeStyle Libre 2 glucose monitoring systems shipped between February and March 2021 due to temperature exposure during shipment that may cause inaccurate readings.
Cardinal Health is recalling 2,357 kits of Dexcom G6 Sensor 3-Pack due to temperature exposure during shipping that may cause inaccurate glucose readings. Affected units were distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling 5,356 boxes of OneTouch Ultra Blue test strips after units were exposed to freezing temperatures during shipping, which may cause inaccurate glucose readings.
Cardinal Health is recalling 1,599 boxes of prefilled pen needles that were exposed to low temperatures during shipping, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.
Cardinal Health Inc. is recalling OneTouch Ultra Test Strips (item 3510443) because temperature excursions during shipping may have compromised glucose measurement accuracy.
Cardinal Health is recalling 531 boxes of OneTouch Ultrasoft Lancets shipped February-March 2021 due to temperature exposure during shipment that may cause inaccurate test results.
Cardinal Health is recalling 8,959 glucose monitoring kits due to temperature exposure during shipping that may result in inaccurate readings. Affected devices were distributed nationwide.
Cardinal Health is recalling Vicks 1.5-gallon vaporizers exposed to temperature excursions during shipping delays in February-March 2021, which may cause inaccurate results. Affected units were distributed in Florida, Georgia, and South Carolina.
Cardinal Health is recalling ACCU-CHEK SMARTVIEW 100 test strips distributed in Florida, Georgia, and South Carolina due to temperature excursions during shipping that may cause inaccurate glucose readings.
Cardinal Health is recalling 375 OptiChamber Diamond Spacer devices due to temperature exposure during shipping that may cause inaccurate medication delivery results. Affected devices were distributed to Florida, Georgia, and South Carolina.
Cardinal Health is recalling AeroChamber PLS spacers exposed to freezing temperatures during shipping, which may cause inaccurate drug delivery results. Affected units shipped between February and March 2021 in Florida, Georgia, and South Carolina.
Cardinal Health is recalling Freestyle Lancets due to temperature exposure during shipping that may cause inaccurate results. Affected devices were distributed in Florida, Georgia, and South Carolina.