BD combined Whitacre and Quincke spinal trays recalled over bupivacaine
BD Spinal Trays containing both a Whitacre 25 G and a Quincke 22 G needle are being recalled as a sub-recall of the Huons bupivacaine product recall. 290 units 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 25 G x 3.5 in and BD Quincke 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 405741, is being recalled. The action covers 290 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 25 G x 3.5 in., BD¿Quincke 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: 405741.
- Manufacturer
- Becton Dickinson & Company
- Hazard
- contained-drug-recall
- acceptance-testing
- class-i
- spinal-anesthesia
Distribution
Distributed nationwide across the United States.
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