Recall Z-1940-2021
Cardinal Health Inc. · initiated March 16, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ONETOUCH DELICA LANCETS 33G 100 COUNT Item Number: 5541628
Codes / lots: NDC/UPC: 812608030019 All lots numbers shipped from 2/23/201 to 3/10/2021
Reason for recall
Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
FDA-determined cause: Environmental control
Action taken
On 03/16/2021, Cardinal Health issued an Urgent Medical Device Removal notice to customer via letter notifying them a recall is being initiated as a precautionary measure as a result of exposure to temperatures outside of the products labeling requirements. Actions Required 1. INSPECT your inventory for the affected product. 2. SEGREGATE and QUARANTINE all affected product. 3. RETURN the enclosed acknowledgment form via fax to 1-817-868-5362 or email to rxrecalls@inmar.com, even if you do not have any product on hand. 4. CONTACT Inmar to arrange for return and credit of any affected product: 1-855-696-2074 (9:00 AM to 5:00 PM, Monday thru Friday)
Details
- Recall number
- Z-1940-2021
- Initiated
- March 16, 2021
- Product code
- FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- Quantity
- 4,896 boxes of 100 lancets
- Distribution
- US Nationwide distribution in the states of FL, GA, SC.
- Recalling firm
- Cardinal Health Inc., Dublin, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1929-2021 Class II | FREESTYLE LANCETS 28G 100CT Item Number:2975670Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |
| Z-1930-2021 Class II | FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |
| Z-1931-2021 Class II | FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |
| Z-1932-2021 Class II | AEROCHAMBER PLS W/MASK LRG BLU Item Number: 1496033Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |
| Z-1933-2021 Class II | BD UF PEN 32GX4MM 100 NANO Item Number: 4292272Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |
| Z-1934-2021 Class II | DEXCOM G6 SENSOR 3 PACK Item Number: 5447552Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |
| Z-1935-2021 Class II | VAPORIZER VICKS 1.5GAL Item Number: 2354942Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |
| Z-1936-2021 Class II | ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |
| Z-1937-2021 Class II | ONETOUCH ULTRASOFT LANCETS 100 COUNT Item Number: 3007788Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |
| Z-1938-2021 Class II | ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |
| Z-1939-2021 Class II | ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |
| Z-1941-2021 Class II | OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |
| Z-1942-2021 Class II | ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2… | 03/16/2021Open, Classified |