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
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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 Number: 405671.
- 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
- Catalog Number: 405671. UDI Number: (01)00382904056711(17)270101(10)B01V275D. Lot Number (Expiration Date): B01V275D (2027-01-01). ***Expansion 07/08/2026 UDI Number: (01)00382904056711(17)270101(10)B01V294D; Lot Number (Expiration Date): B01V294D (2027-01-01).
- Product quantity
- 0 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Franklin Lakes
- State
- NJ
- Country
- United States
- Event id
- 98842
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