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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Embecta Corp.
- Affected units
- 185,900
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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