Device 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.
Z-1689-2020
Product summary
- Event
- Event 85338
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,170 units (US: 420 and OUS: 7,750)
- Official record key
device-enforcement:Z-1689-2020
Official wording
Reason: Sterility compromised due to packaging pouches that may not be sealed properly
Code information: Lot Numbers: 0001303256 and 0001303257
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.
Derived failure modes
-
Sterility assurance
Sterility compromised