—#34012

Product

A1645-25 SPINAL(FL)WHITACRE W/DRUGS

FDA product code: CAZ — Anesthesia Conduction Kit
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: Lot Number: K515828

Why it was recalled

Trays contain Hospira recalled 2ml drug ampuls of 5% Lidocaine Hydrochloride with 7.5% Dextrose Injection, (NDC 0074-4712-01, lot number 09-568-DK) Hospira, Inc. was recalling the 2ml drug vials of 5% Lidocaine Hydrochloride w/ 7.5% Dextrose lot number 09-568-DK). The drug is being recalled due to reports of particulate in the product.

Root cause (FDA determination)

Other

Action the firm took

Smiths Medical notifed Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004. Customers and dealers are directed to fax back the attached Reply Letter

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 10 Bowman Dr, Keene, New Hampshire 03431-5043

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2004-07-02
Posted by FDA: 2004-07-30
Terminated: 2006-05-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.