BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704.
Enforcement
- Recall Number
- Z-2255-2026
- Event ID
- 98842
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Becton Dickinson & Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 10, 2026
- Initiation Date
- April 27, 2026
- Classification Date
- May 29, 2026
- Address
- 1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States
Description
BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Numbers: 400866, 405672, 405673, 405674, 405675, 405709, 405721, 405723, 406704.
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during an FDA manufacturing facility inspection, citing specific quality deficiencies related to acceptance testing.
1. Catalog Number: 400866. UDI Number: (01)10885403469497(17)270101(10)B01V232D. Lot Number (Expiration Date): B01V232D (2027-01-01). 2. Catalog Number: 405672. UDI Number: (01)00382904056728(17)270101(10)B03V267D. Lot Number (Expiration Date): B03V267D (2027-01-01). 3. Catalog Number: 405673. UDI Numbers: (01)00382904056735(17)261001(10)B01V225D, (01)00382904056735(17)270101(10)B01V281D, (01)00382904056735(17)261001(10)B02V211D, (01)00382904056735(17)261001(10)B02V217D. Lot Numbers (Expiration Date): B01V225D (2026-10-01), B01V281D (2027-01-01), B02V211D (2026-10-01), B02V217D (2026-10-01). 4. Catalog Number: 405674. UDI Number: (01)00382904056742(17)261001(10)B01V218D. Lot Number (Expiration Date): B01V218D (2026-10-01). 5. Catalog Number: 405675. UDI Numbers: (01)00382904056759(17)261001(10)B01V183D, (01)00382904056759(17)260901(10)B01V198D. Lot Numbers (Expiration Date): B01V183D (2026-10-01), B01V198D (2026-09-01). 6. Catalog Number: 405709. UDI Numbers: (01)00382904057091(17)261001(10)B02V202D, (01)00382904057091(17)260628(10)B02V174D. Lot Numbers (Expiration Date): B02V202D (2026-10-01), B02V174D (2026-06-28). 7. Catalog Number: 405721. UDI Number: (01)00382904057213(17)270101(10)B02V227D. Lot Number (Expiration Date): B02V227D (2027-01-01). 8. Catalog Number: 405723. UDI Number: (01)00382904057237(17)260628(10)B01V174D, (01)00382904057237(17)270101(10)B02V254D, (01)00382904057237(17)261001(10)B01V189D. Lot Numbers (Expiration Date): B01V174D (2026-06-28), B02V254D (2027-01-01), B01V189D (2026-10-01). 9. Catalog Number: 406704. UDI Number: (01)00382904067045(17)270101(10)B02V246D. Lot Number (Expiration Date): B02V246D (2027-01-01).
Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SD, TN, TX, UT, VA, WA, WI, WV, WY.
13,320 units