FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1181-2008
- Recalling firm
- Hospira Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2008-01-03
- Posted
- 2008-08-06
- Terminated
- 2010-03-09
- 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 verification form verifying that they have removed the software from their system. The letter listed commercially available software packages that the account could validate and implement in their facility. Any questions concerning the utility software withdrawal were directed to Hospira at 1-800-241-4002, option 4, then option 1.
- Quantity
- 127 CDs
- Distribution
- Nationwide Distribution and Canada
- Lot, serial or model codes
- Version 1.0, all CDs
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MEA
- Firm FEI
- 3013319212
- Firm city
- Lake Forest
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28