Bard Jamshidi Bone Marrow Biopsy Needle Recalled for Sterility Compromise
Bard Peripheral Vascular Inc is recalling Jamshidi Bone Marrow Biopsy/Aspiration Needles because packaging pouches may not be sealed properly, 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 with compromised sterility, which poses a risk of infection (harm) to patients, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 8,170 units of Jamshidi Bone Marrow Biopsy/Aspiration Needles, with Luer Lock Adapter 11GX4 ASP, Sterile (Product Code: DJ4011X). The recall affects Lot Numbers 0001303256 and 0001303257. The devices are intended for the posterior iliac crest biopsy technique and consist of an outer cannula with a handle and an inner stylet.
The recall is being conducted because the packaging pouches may not be sealed properly, which compromises the sterility of the devices. The affected units were distributed worldwide, including nationwide in the United States (specifically in FL, IL, NJ, NY, OH, TN, and VA) and in Australia, India, Japan, Malaysia, New Zealand, the Philippines, and Singapore.
Healthcare providers and facilities should stop using the affected devices and contact Bard Peripheral Vascular Inc for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.
- Manufacturer
- Bard Peripheral Vascular Inc
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)
- Lot Numbers: 0001303256 and 0001303257
Distribution
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