Date Initiated by Firm |
February 09, 2007 |
Date Posted |
August 07, 2007 |
Recall Status1 |
Terminated 3 on May 28, 2008 |
Recall Number |
Z-1129-2007 |
Recall Event ID |
38341 |
510(K)Number |
K981816
|
Product Classification |
IV Administration Sets - Product Code FPA
|
Product |
Curlin Medical Administration Sets: Model Numbers 340-4111, IV Administration Sets. |
Code Information |
Model Numbers 340-4111- Lot # D628223, D627616, D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716 |
Recalling Firm/ Manufacturer |
Curlin Medical Llc 15751 Graham St Huntington Beach CA 92649-1630
|
For Additional Information Contact |
Marc Drobnack 714-893-2200 Ext. 141
|
Manufacturer Reason for Recall |
The Administration Sets may leak at the reservior bag.
|
FDA Determined Cause 2 |
Other |
Action |
A Field Correction Advisory (Recall Letter) was issued on February 9, 2007 to the firm's one US Customer (distributor): B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets 340-4111- Lot # D628223 and D627616 because the affected lots do not meet acceptable performance levels.
A second Field Correction Advisory (Recall Letter) was issued on March 15, 2007 to B. Braun Medical Inc. recalling Curlin Medical, Inc. Administration Sets: 340-4111- Lot # D628223, D6276l6 ,D620544, D630503; 340-4127- Lot# D620104; 340-4119- Lot# D623716 because the affected lots do not meet acceptable performance levels. |
Quantity in Commerce |
25, 280 |
Distribution |
One US Customer (distributor): B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
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.
|
510(K) Database |
510(K)s with Product Code = FPA and Original Applicant = BECTON DICKINSON CURLIN, LLC.
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