BD Quincke spinal trays recalled over Huons bupivacaine quality issues
BD Spinal Trays with a Quincke 22 G needle are being recalled as a sub-recall of the Huons bupivacaine product recall. 990 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 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 405609, is being recalled. The action covers 990 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 numbers 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¿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: 405609.
- Manufacturer
- Becton Dickinson & Company
- Hazard
- contained-drug-recall
- acceptance-testing
- class-i
- spinal-anesthesia
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 (2)
- Catalog Number: 405609. UDI Numbers: (10)00382904056094(17)261001(10)B01V212D
- B01V238D (2027-01-01).
Distribution
Distributed nationwide across the United States.
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