| Class 2 Device Recall Baxter Clearlink System NonDEHP 3 Port Adapter | |
Date Initiated by Firm | September 09, 2010 |
Date Posted | October 27, 2010 |
Recall Status1 |
Terminated 3 on September 07, 2011 |
Recall Number | Z-0150-2011 |
Recall Event ID |
56718 |
510(K)Number | K913627 |
Product Classification |
set, administration, intravascular - Product Code FPA
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Product | Baxter Clearlink System Non-DEHP 3 Port Adapter, 1.2 mL, 2 Luer Activated Valves for IV Access, Male Luer Lock Adapter; a sterile Rx device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N8334
For the administration of drugs and solutions to a patient's vascular system through a vascular access device. |
Code Information |
product 2N8334, lots UR214494, UR215400, UR232462, UR238121, UR269787, UR278440, UR283358, UR292524, UR299628, UR305292, UR312454, UR312611, UR322339, UR333070, UR345587, UR345876, UR355784, UR383984, UR07K21064, UR07K30149, UR07L07210, UR07L19173, UR08A10124, UR146118, UR158816, UR158881 and UR158915 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. Rt. 120 & Wilson Rd Round Lake IL 60073
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For Additional Information Contact | Center for One Baxter 800-422-9837 |
Manufacturer Reason for Recall | During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch. |
FDA Determined Cause 2 | Package design/selection |
Action | Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they could comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST. |
Quantity in Commerce | 108,000 sets |
Distribution | Worldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile. |
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
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