Recall Z-2146-2011 ยท MEB Pump, Infusion, Elastomeric
Baxter Healthcare Corp.
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.
| Date | May 5, 2011 (initiated Mar 15, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 reg |
| Quantity | 3,696 units |
| Distribution | Worldwide Distribution - USA including AL and the countries of Mexico and Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982102 | SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY Baxter Healthcare Corp, Sep 4, 1998 |