Is FREESTYLE LANCETS 28G 100CT Item Number:2975670 recalled?

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. Status: Voluntary: Firm initiated Initial Firm Notification: Letter Distribution: US Nationwide distribution in the states of FL, GA, SC.

Medium RiskFDA Device

Cardinal Health Inc.: 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.

Agency Publication Date: June 23, 2021

Affected Products

Product: FREESTYLE LANCETS 28G 100CT Item Number:2975670

NDC/UPC: 699073130013 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084

NDC/UPC: 57599000101 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877

NDC/UPC: 57599080000 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033

NDC/UPC: 456074613 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: BD UF PEN 32GX4MM 100 NANO Item Number: 4292272

NDC/UPC: 8290320122 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: DEXCOM G6 SENSOR 3 PACK Item Number: 5447552

NDC/UPC: 8627005303 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: VAPORIZER VICKS 1.5GAL Item Number: 2354942

NDC/UPC: 328785101508 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174

NDC/UPC: 353885009713 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788

NDC/UPC: 353885393102 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443

NDC/UPC: 353885994255 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610

NDC/UPC: 812608030026 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628

NDC/UPC: 812608030019 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326

NDC/UPC: 8373982700 All lots numbers shipped from 2/23/201 to 3/10/2021

Product: ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862

NDC/UPC: 365702493100 All lots shipped from 2/23/201 to 3/10/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87787

Status: Active

Manufacturer: Cardinal Health Inc.

Manufactured In: United States

Units Affected: 14 products (377 boxes of 100 lancets; 8,959 kits; 2,115 kits; 100 units; 1,599 boxes of 100 needles; 2357 kits; 1 unit; 5,356 boxes of 100 strips; 531 boxes of 100 lancets; 144 boxes of 25 strips; 2,315 boxes of 100 lancets; 4,896 boxes of 100 lancets; 375 units; 537 boxes of 100 strips)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products