Recall Z-0482-2013
Hospira Inc. · initiated October 26, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Plum A+ Hyperbaric Single Channel Infusion Pumps with Hospira MedNet Software and a Connectivity Engine peripheral module that provides wired Ethernet and wireless local networking, allowing the MedNet software to download drug libraries to the infuser and enable the auto-programming feature; Hospira, Inc., Lake Forest, IL 60045; pump list number 11005, module list number 11006 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
Codes / lots: pump list number 11005 and module list number 11006; all serial numbers
Reason for recall
The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the knob is turned clockwise.
FDA-determined cause: Device Design
Action taken
The firm, Hospira Inc. sent "URGENT DEVICE FIELD CORRECTION" letters dated October 26, 2012 to all affected customers. The letters identified the products, problem and action(s) to be taken. The customers were instructed to read the information provided carefully, complete the attached Reply Form and return it to the firm via fax at 1-877-650-8667. The letter states that the System Operating Manual will be updated to clarify the instructions for setting the volume, and that the updated manuals will be sent as soon as they are available. Customers were instructed to notify their consignees if they have further distributed the affected product. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for additional information and technical assistance.
Details
- Recall number
- Z-0482-2013
- Initiated
- October 26, 2012
- Posted by FDA
- December 7, 2012
- Terminated
- November 14, 2016
- Product code
- FRN – Pump, Infusion
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of Australia, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Lavenia, South…
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0481-2013 Class II | Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired…The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not… | 10/26/2012Terminated |
| Z-0483-2013 Class II | Plum A+ Single Channel Infusion Pumps with Hospira Mednet Software and a Connectivity…The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not… | 10/26/2012Terminated |