Becton Dickinson Recalls Jamshidi Bone Marrow Biopsy Needles Due to Sterility Concerns
Becton Dickinson is recalling 700 units of Jamshidi Crown Bone Marrow biopsy needles because product pouches may not be sealed properly, potentially compromising sterility.
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: The recall involves a medical device where a failure in packaging could compromise sterility, posing a risk of infection. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling 700 units of 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needles with MAC (Catalog Number: TMJ4008). The recall is due to a defect where product pouches may not be sealed properly, which could compromise the sterility of the device.
The affected lot number is 0001159474, with an expiration date of August 31, 2022. The distribution pattern includes California, Illinois, and Taiwan.
Consumers and healthcare facilities should stop using these needles and contact Becton Dickinson & Company for further instructions or a replacement.
The recalled product
- Product
- 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Needles
- Affected units
- 700
Distribution
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