Date Initiated by Firm | June 30, 2008 |
Date Posted | September 23, 2008 |
Recall Status1 |
Terminated 3 on May 05, 2009 |
Recall Number | Z-2412-2008 |
Recall Event ID |
49078 |
510(K)Number | K781744 K790062 K955585 |
Product Classification |
Burette Set - Product Code FPA
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Product | Add-On Burette Set with 150 ml burette and Ultrasite Injection Site without automatic shutoff. Item/Catalog number 375111. The product is shipped 20 units per carton. The product is for use after activation of shutoff valve (re-floating of disk) |
Code Information |
Lot number 60999546 exp 3/31/2013 |
Recalling Firm/ Manufacturer |
B. Braun Medical, Inc. 901 Marcon Boulevard Allentown PA 18109-9512
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For Additional Information Contact | Customer Support Department 800-227-2862 |
Manufacturer Reason for Recall | incorrect burette was packaged with the product |
FDA Determined Cause 2 | Mixed-up of materials/components |
Action | The firm issued a Product Removal Notice dated 6/20/08 via USPS Certified Mail with registered receipt mail to all customers in receipt of affected product. The notice informs customers of the problem, to cease use and distribution immediately, and to return the product. Contact B. Braun Medical at 1-800-227-2862 for assistance. |
Quantity in Commerce | 2560 units |
Distribution | Nationwide. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = FPA 510(K)s with Product Code = FPA
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