BD Whitacre 22G spinal trays recalled in Huons bupivacaine sub-recall
BD Spinal Trays with Whitacre needle 22 G, which contain bupivacaine with dextrose, are being recalled as a sub-recall of the Huons bupivacaine product recall. 330 units are affected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.
Plain-English summary
The BD Spinal Tray with BD Whitacre Needle 22 G x 3.5 in, containing lidocaine HCl 1% (5 mL) and bupivacaine HCl 0.75% with dextrose 8.25% (2 mL), catalog number 405645, is being recalled. The action covers 330 units.
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 FDA classified the action as Class I, its most serious classification.
Distribution was nationwide across a large number of states. The trays are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog number, UDI and lot numbers in the recall notice, quarantine it, and follow the instructions issued by BD.
The recalled product
- Product
- BD¿Spinal Tray with BD¿Whitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL, bupivacaine HCL (0.75%) with dextrose (8.25%), 2 mL (marcaine). Catalog Number: 405645.
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 330
Distribution
Part of a larger recall action
This product is one of 10 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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