Bard Jamshidi Evolve Bone Marrow Needle Recall Due to Open Packaging
Bard recalls Jamshidi Evolve bone marrow needles due to incomplete packaging seals that could compromise sterility. The recall affects 560 devices distributed in the U.S. and internationally.
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: This is a Class II FDA recall of a medical device used in invasive procedures. No illnesses or injuries have been reported. The hazard—non-sterility due to open packaging seals—represents a potential risk of harm with sterile diagnostic equipment, meeting the criterion for Score 3 (High).
Plain-English summary
Bard Peripheral Vascular Inc has recalled 560 units of the EJM4011 Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle (11G x 10cm).
The recall was initiated due to complaints regarding incomplete or open packaging seals. These packaging failures could potentially allow the sterile medical device to become non-sterile, which poses a risk when used for invasive bone marrow procedures.
The recalled devices were distributed nationwide in the United States (Arizona, Connecticut, Washington D.C., Florida, Illinois, Massachusetts, Michigan, Missouri, New York, Oklahoma, Texas, and Virginia) as well as internationally in Australia, Belgium, China, EMEA countries, Japan, Mexico, Saudi Arabia, Singapore, and Taiwan. The affected serial numbers are 0001330769 and 0001331231, with catalog number EJM4011.
Individuals and healthcare facilities should contact Bard Peripheral Vascular Inc if they have received devices with catalog number EJM4011 and the affected serial numbers.
The recalled product
- Product
- EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- non-sterile
- open-packaging
- contamination-risk
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 (3)
- Catalog Number/UDI: EJM4011/ (01)10885403464157(17)241031(10)0001330769
- Serial Numbers: 0001330769
- 0001331231
Distribution
Distributed nationwide across the United States.
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