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.
- Company
- Baxter Healthcare Corp. Rt
- Recall Initiated
- March 15, 2011
- Posted
- May 5, 2011
- Terminated
- March 12, 2012
- Recall Number
- Z-2146-2011
- Quantity
- 3,696 units
- Firm Location
- Round Lake, IL
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.
Distribution
Worldwide Distribution - USA including AL and the countries of Mexico and Spain
Lot / Code Info
product code 2C1071KJP, lot 10H054 and product code 2C1073KJP, lot 10H054
Root Cause
Labeling mix-ups
Action Taken
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.