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.
Reported: April 15, 2020 Initiated: March 17, 2020 #Z-1689-2020
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
Details
- Recalling Firm
- Bard Peripheral Vascular Inc
- Units Affected
- 8,170 units (US: 420 and OUS: 7,750)
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of FL, IL, NJ, NY, OH, TN, VA and countries of AUSTRALIA, INDIA, JAPAN, MALAYSIA, NEW ZEALAND, PHILIPPINES and SINGAPORE.
- Location
- Tempe, AZ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bard Peripheral Vascular Inc. Units affected: 8,170 units (US: 420 and OUS: 7,750).
Why was this product recalled? ▼
Sterility compromised due to packaging pouches that may not be sealed properly
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 15, 2020. Severity: Moderate. Recall number: Z-1689-2020.
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