[pending] BD¿Spinal Tray with BD¿Whitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.
Pending LLM rewrite. Source: FDA_DEVICE Z-2257-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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.
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 1. Catalog Number: 405637. UDI Numbers: (01)00382904056377(17)260628(10)B01V160D
- (01)00382904056377(17)270101(10)B01V241D
- (01)00382904056377(17)270101(10)B01V265D
- B01V241D (2027-01-01)
- B01V265D (2027-01-01)
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
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