BD Whitacre 25G spinal trays recalled in Huons bupivacaine sub-recall

Plain-English summary

The BD Spinal Tray with BD Whitacre Needle 25 G x 3.5 in, containing lidocaine HCl 1% (5 mL) and bupivacaine HCl 0.75% with dextrose 8.25% (2 mL), catalog numbers 405637 and 405707, is being recalled. The action covers 5,940 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 numbers, UDI codes 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.; 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 — Spinal anesthesia tray

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.

Distribution

Distributed nationwide across the United States.

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