Z-0154-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 27, 2021
- Initiation Date
- August 24, 2021
- Termination Date
- December 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 360 devices
Product Description
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.
Reason for Recall
Due to misbranded products shipped to customers.
Distribution Pattern
U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None
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