|
Class 2 Device Recall Baxter Single Day Infusor 2 mL/h System |
|
Date Initiated by Firm |
March 15, 2011 |
Date Posted |
May 05, 2011 |
Recall Status1 |
Terminated 3 on March 12, 2012 |
Recall Number |
Z-2146-2011 |
Recall Event ID |
58181 |
510(K)Number |
K982102
|
Product Classification |
Pump, infusion, elastomeric - Product Code MEB
|
Product |
Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; Baxter Healthcare Corporation, Deerfield, IL 60015; REF 2C1071KJP The Infusor device is indicated for patients requiring slow, continuous intravenous, intra-arterial, epidural, or subcutaneous administration of medications. |
Code Information |
product code 2C1071KJP, lot 10H054 and product code 2C1073KJP, lot 10H054 |
Recalling Firm/ Manufacturer |
Baxter Healthcare Corp. Rt. 120 & Wilson Rd Round Lake IL 60073
|
For Additional Information Contact |
Center for One Baxter 800-422-9837
|
Manufacturer Reason for Recall |
Some of the Single Day Infusor System 2 mL/h have a foil over-pouch that was incorrectly labeled as the Half Day Infusor System 5 mL/h, product code 2C1073KJP, lot 10H054.
|
FDA Determined Cause 2 |
Labeling mix-ups |
Action |
Baxter Healthcare Corp. sent Urgent Product Recall letters dated March 15, 2011, via first class mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The accounts were requested to examine all of their inventory locations for both product code 2C1071KJP and 2C1073KJP, lot 10H054, and return the affected lot for replacement or credit. The accounts were also requested to complete the attached customer reply form listing the number of held for return, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Center for One Baxter at 1-800-422-9837. |
Quantity in Commerce |
3,696 units |
Distribution |
Worldwide Distribution - USA including AL and the countries of Mexico and Spain |
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 = MEB and Original Applicant = BAXTER HEALTHCARE CORP.
|
|
|
|