| | Class 2 Recall
Baxter Single Day Infusor 2 mL/h System |  |
| Date Posted |
May 05, 2011 |
| Recall Number |
Z-2146-2011 |
| 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, Illinois 60073 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Center for One Baxter
800-422-9837
|
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.
|
| 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 |
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