BD Nano 2nd Gen Pen Needles recalled for post-expiration distribution
Embecta Corp. is recalling BD Nano 2nd Gen Pen Needles that were distributed at or after their February 29, 2024 expiration date. Using expired needles cannot guarantee sterility and integrity.
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: Class II recall of a medical injection device with no reported illnesses or injuries. The hazard—inability to guarantee sterility of a parenteral delivery device—is significant but theoretical, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Embecta Corp. is recalling BD Nano 2nd Gen Pen Needles (32G X 4mm, Model 320551), sterile single-use devices for medication injection. The affected product includes approximately 185,900 units distributed nationwide in the United States, with lot numbers 9044773 and 3750144 (the latter contained in the Patient Counseling Sample Toolbox).
The needles were shipped at or after their labeled expiration date of February 29, 2024. Using a medical device past its expiration date cannot guarantee the device's sterility and integrity, which are critical attributes for safe parenteral administration of medications.
Patients and healthcare providers who received these needles after the expiration date should not use them. Anyone who has used one of these needles and has concerns about device sterility should consult their healthcare provider.
The recalled product
- Product
- BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/C
- Manufacturer
- Embecta Corp.
- Hazard
- sterility-compromise
- device-expiration
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)
- it has a marketing reference number of 6484755 and lot 3750144.
Distribution
Distributed nationwide across the United States.
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