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Terminated

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

FDA Recall Z-1440-04 · Posted 2004-09-09

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeBSP
Date Initiated2004-07-06
Date Terminated2004-11-30
Product Quantity2261 cases

Reason for Recall

drug ampuls in kits contain particulates

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932569PENCIL POINT SPINAL NEEDLE AND TRAYB. Braun of America, Inc. · 1994-01-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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