Z-1440-04

Standard and Custom Spinal Trays with 7.5% Dextrose Injection USP 2 ml ampul

Name: Z-1440-04 Standard and Custom Spinal Trays with 7.5% Dextrose Injection USP 2 ml ampul
Creator: B. Braun Medical, Inc.
Published: 2004-07-06
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2004-07-06 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of Standard and Custom Spinal Trays with 7.5% Dextrose Injection USP 2 ml ampul on 2004-07-06. The reason FDA records is "drug ampuls in kits contain particulates". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1440-04
Status: Terminated
Initiated: 2004-07-06
Posted: 2004-09-09
Terminated: 2004-11-30
Recalling firm: B Braun Medical Inc
Product: Standard and Custom Spinal Trays with 7.5% Dextrose Injection USP 2 ml ampul
Product code: BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Reason for recall: drug ampuls in kits contain particulates
FDA root cause: Other
Action: The recalling firm/kit manufacturer issued a recall letter dated 7/8/04 to its customers informing them of the problem and to return the product.
Quantity in commerce: 2261 cases
Distribution: The products were shipped to 145 medical facilities and 79 distributors nationwide. The products were also shipped to 6 government accounts in FL, NC, NY, OH, and PA.
Product codes and lots: Catalog number 333027 Lot number 60544516, Catalog number 333200 Lot number 60536446, Catalog number 333210 Lot numbers 60536450 and 60542855, Catalog number 333230 Lot number 60542857, Catalog number 333742 Lot numbers 60536470, 60544549, and 60544550, Catalog number 333752 Lot number 60544557, Catalog number 333852 Lot numbers 60536493 and 60544563, Catalog number 333861 Lot numbers 60517577 and 60517578, Catalog number 333872 Lot number 60544582, Catalog number 560074 Lot number 60537371, Catalog number 560123 Lot number 60549408, Catalog number 560130 Lot number 60549409, Catalog number 560156 Lot number 60547692, Catalog number 560176 Lot number 60537460, Catalog number 560214 Lot number 60563428, Catalog number 560269 Lot number 60540604, Catalog number 560327 Lot numbers 60537472 and 60549429, Catalog number 560386 Lot number 60549439, Catalog number 560397 Lot number 60527954, Catalog number 560399 Lot number 60540619, Catalog number 560408 Lot number 60537475, Catalog number 560436 Lot number 60549863, Catalog number 560485 Lot number 60540907, and Catalog number 560505 Lot number 60566553.

Product code BSP

K932569Class IIPencil Point Spinal Needle and TrayB. Braun of America, Inc. / cleared 1994-01-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)