Jamshidi Bone Marrow Biopsy Tray Recalled Due to Misbranding
Bard Peripheral Vascular Inc. is recalling 360 Jamshidi Bone Marrow Biopsy Trays (Catalog # BEK3411, Lot # 0001378561) due to misbranded labeling. The FDA classified this as a Class II recall affecting healthcare facilities in 16 U.S. states and Puerto Rico.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The hazard is limited to misbranding (labeling/documentation non-compliance) with no described safety defect, no reported illnesses, injuries, or hospitalization. Per the severity rubric, this falls under 'minor labeling errors' classified as Moderate (Score 2). FDA Class II designation without reported harm does not elevate the score.
Plain-English summary
Bard Peripheral Vascular Inc. has recalled the Jamshidi Bone Marrow Biopsy Tray (Catalog # BEK3411), a single-use medical device intended to aspirate bone marrow from the sternum or iliac crest. The recalled lot includes 360 devices (Lot # 0001378561, manufactured August 19, 2020, with an expiration date of December 31, 2021).
The recall was initiated due to misbranded products being shipped to customers. The FDA classified this as a Class II recall.
The affected products were distributed to healthcare facilities in California, Georgia, Hawaii, Illinois, Indiana, Louisiana, Missouri, Mississippi, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, and Washington.
Affected healthcare facilities should discontinue use of the recalled lot and contact Bard Peripheral Vascular Inc. or the FDA for guidance on product return, replacement, or destruction. Healthcare providers should review any labeling corrections issued by the manufacturer.
The recalled product
- Product
- Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous…
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 360
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 (9)
- Cat No.: BEK3411
- Lot /Serial No.: 0001378561
- UDI # BEK3411
- Lot BEK3411
- Lot 0001378561
- (01)50885403057258(17)211231(10)0001378561
- Mfg. Date 08/19/2020
- Exp. Date: 12/31/2021
- Qty: 360
Distribution
Part of a larger recall action
This product is one of 2 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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