Recall Z-1689-2020— Bard Peripheral Vascular Inc
Class II · Terminated
Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2020-03-17, terminated 2024-07-15. It names one FDA 510(k) clearance: K171531. 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.. Reason: Sterility compromised due to packaging pouches that may not be sealed properly.
- Recalling firm
- Bard Peripheral Vascular Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-03-17
- Terminated
- 2024-07-15
- Firm location
- Tempe, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Sterility compromised due to packaging pouches that may not be sealed properly
Data sourced from openFDA. This site is unofficial and independent of the FDA.