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U.S. Department of Health and Human Services

Class 2 Device Recall Normal Saline 10ml in 12ml Syringe

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  Class 2 Device Recall Normal Saline 10ml in 12ml Syringe see related information
Date Initiated by Firm July 30, 2007
Date Posted September 20, 2007
Recall Status1 Terminated 3 on April 01, 2008
Recall Number Z-1236-2007
Recall Event ID 39386
510(K)Number K002142  
Product Classification saline flush syringe - Product Code NGT
Product Normal Saline 10ml in 12ml Syringe. The product is shipped in 120 units per carton.
Code Information Item number 531587. Lot numbers 070507SFR exp 5/09, 070523SFR exp 5/09 070529SFR exp 6/09, 070601SFR exp 6/09, 070605SFR exp 6/09, 070608SFR exp 6/09, 070613SFR exp 6/09, 070618SFR exp 6/09, 070620SFR exp 6/09, and 070625SFR exp 6/09.
Recalling Firm/
B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information Contact Kimberly Paris
Manufacturer Reason
for Recall
Particulate matter in product.
FDA Determined
Cause 2
Action The recalling firm issued a Product Removal Notice to the distributors on 7/31/07 informing them of the problem and the need to contact their customers. Product should be returned to the recalling firm for destruction. On 9/14/07, the recalling firm issued a press release to alert any consumer that may have the product of the particulate problem.
Quantity in Commerce 1,292,520 units
Distribution The products were shipped to distributors nationwide.
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 = NGT and Original Applicant = EMT-RX