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U.S. Department of Health and Human Services

Class 2 Device Recall Spinal Trays

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  Class 2 Device Recall Spinal Trays see related information
Date Initiated by Firm July 06, 2004
Date Posted September 09, 2004
Recall Status1 Terminated 3 on November 30, 2004
Recall Number Z-1440-04
Recall Event ID 29938
510(K)Number k932569  
Product Classification Needle, Conduction, Anesthetic (W/Wo Introducer) - Product Code BSP
Product Standard and Custom Spinal Trays with 7.5% Dextrose Injection USP 2 ml ampul
Code Information 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.
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information Contact Art Morse
610-266-0500 Ext. 2328
Manufacturer Reason
for Recall		 drug ampuls in kits contain particulates
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BSP and Original Applicant = B. BRAUN OF AMERICA, INC.
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