Z-1689-2020 Class II Terminated
FDA device recall Z-1689-2020 was initiated by Bard Peripheral Vascular Inc on March 17, 2020 and is designated Class II. Reason for recall: Sterility compromised due to packaging pouches that may not be sealed properly The recall status is terminated (terminated July 15, 2024). Affected quantity: 8,170 units (US: 420 and OUS: 7,750).
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2020
- Initiation Date
- March 17, 2020
- Termination Date
- July 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,170 units (US: 420 and OUS: 7,750)
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
Distribution Pattern
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.
Code Information
Lot Numbers: 0001303256 and 0001303257