Prefilled Pen Needles Recalled Due to Temperature Exposure During Shipping
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. Temperature exposure during shipping may cause inaccurate results in a medical device used for medication delivery, representing a risk-of-harm scenario that meets the High (3) severity criterion.
Plain-English summary
Cardinal Health Inc. is recalling 1,599 boxes of BD UF PEN 32GX4MM 100 NANO prefilled pen needles (Item Number 4292272, NDC/UPC 8290320122) due to potential device failure from temperature exposure during shipping.
During the shipping period from February 23, 2021 to March 10, 2021, affected devices were exposed to temperatures as low as 31.9°F for approximately 2 hours and 15 minutes. This temperature excursion may cause the devices to produce inaccurate results.
The recalled devices were distributed nationwide in Florida, Georgia, and South Carolina. Patients or healthcare providers who received these devices should discontinue use and contact Cardinal Health or their healthcare provider for replacement units.
If you believe you have received affected devices, do not use them and consult with your healthcare provider or Cardinal Health for instructions on obtaining replacement products.
The recalled product
- Product
- BD UF PEN 32GX4MM 100 NANO Item Number: 4292272
- Manufacturer
- Cardinal Health Inc.
- Hazard
- temperature-exposure
- inaccurate-results
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- NDC/UPC: 8290320122 All lots numbers shipped from 2/23/201 to 3/10/2021
Distribution
Distributed nationwide across the United States.
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