Recall Z-1181-2008 ยท MEA Pump, Infusion, Pca
Hospira Inc.
Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is entitled "LifeCare PCA Barcode Label Utility Program." This software program is designed to allow entry of each drug concentration into a formulation library on a pharmacy computer for standardized printing of barcode labels for compounded drug product vials.
| Date | Aug 6, 2008 (initiated Jan 3, 2008) |
| Status | Terminated |
| Reason | Incorrect dosage labels created: Customers have experienced independent changes in drug concentration (mg/mL to mcg/mL and vice versa) and expiration dates, and the addition of trailing zeros to the barcodes. |
| Root cause | Software design |
| Action | Hospira sent letters dated 1/3/08 to the immediate recipients of the product via FedEx overnight letter on the same date. The letters informed the accounts of the reports of independent changes in drug concentration while editing a saved formulation using the Hospira LifeCare PCA Label Utility Software CD that was provided to some customers in a Hospira MedNet Drug Library Creation Team Introductory Kit-LifeCare PCA kit. The accounts were requested to remove the utility from any PC in their facility on which it is currently installed, destroy the CD and sign and return the enclosed removal v |
| Quantity | 127 CDs |
| Distribution | Nationwide Distribution and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.