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Becton Dickinson & Company: 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 (marcai

Medical DevicesSource: FDA (device) · Date: 2026-06-10

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Becton Dickinson & Company
Product
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: 405637, 405707.
Reason / hazard
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.
Classification
Class I
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-04-27
Code info
1. Catalog Number: 405637. UDI Numbers: (01)00382904056377(17)260628(10)B01V160D, (01)00382904056377(17)270101(10)B01V241D, (01)00382904056377(17)270101(10)B01V265D, (01)00382904056377(17)261001(10)B02V183D. Lot Numbers (Expiration Date): B01V160D (2026-06-28), B01V241D (2027-01-01), B01V265D (2027-01-01), B02V183D (2026-10-01). 2. Catalog Number: 405707. UDI Number: (01)00382904057077(17)270101(10)B02V230D. Lot Number (Expiration Date): B02V230D (2027-01-01).
Product quantity
5,940 units
Voluntary mandated
Voluntary: Firm initiated
City
Franklin Lakes
State
NJ
Country
United States
Event id
98842
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