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U.S. Department of Health and Human Services

Class 2 Device Recall AddOn Burette Set with automatic shutoff

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 Class 2 Device Recall AddOn Burette Set with automatic shutoffsee related information
Date Initiated by FirmJune 30, 2008
Date PostedSeptember 23, 2008
Recall Status1 Terminated 3 on May 05, 2009
Recall NumberZ-2413-2008
Recall Event ID 49078
510(K)NumberK781744 K790062 K955585 
Product Classification Burette Set - Product Code FPA
ProductAdd-On Burette Set with 150 ml burette 7 Ultrasite Injection Site with automatic shutoff, 20 in US1525M Metriset Add-on Burette Set. Item/Catalog number 375059. 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 60999544 exp 3/31/2013
Recalling Firm/
Manufacturer		 B. Braun Medical, Inc.
901 Marcon Boulevard
Allentown PA 18109-9512
For Additional Information ContactCustomer 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
ActionThe 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 Commerce2340 units
DistributionNationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPA
510(K)s with Product Code = FPA
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