FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: A3015-25 SPINAL (SDD) W/DRUGS
- Recall number
- Z-1294-04
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- A3015-25 SPINAL (SDD) W/DRUGS
- Status
- Terminated
- Initiated
- 2004-07-02
- Posted
- 2004-07-30
- Terminated
- 2006-05-02
- Reason
- 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
- Other
- Action
- 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
- Quantity
- 200 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Numbers: K517099, K521073, K521413
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAZ
- Firm FEI
- 1217052
- Firm city
- Keene
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28