Device product
Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable.
Z-0154-2022
Product summary
- Event
- Event 88674
- Status
- Terminated
- Classification
- Class II
- Quantity
- 360 devices
- Official record key
device-enforcement:Z-0154-2022
Official wording
Reason: Due to misbranded products shipped to customers.
Code information: Cat No.: BEK3411; Lot /Serial No.: 0001378561; UDI # BEK3411, Lot BEK3411, Lot BEK3411, Lot 0001378561; (01)50885403057258(17)211231(10)0001378561; Mfg. Date 08/19/2020; Exp. Date: 12/31/2021; Qty: 360
Distribution pattern: U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None
Derived failure modes
-
Labeling or packaging
misbranded