Atlas FDA

15810-21 SPINAL(DD) 24G SPROTTE W/DRUGS

FDA device recall Z-1259-04 · posted 2004-07-30 · Terminated

Recall details

Recalling firm
Smiths Medical ASD, Inc.
Reason for recall
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.
Action taken
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
Root cause
Other
Status
Terminated
Product code
CAZ
Quantity affected
120 units
Distribution
Nationwide
Date initiated
2004-07-02
Date posted
2004-07-30
Date terminated
2006-05-02
Location
Keene, NH

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