FDAClass IIDecember 19, 2012

Plum A+ Single Channel Infusion Pumps with recall

Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake…

Why was Plum A+ Single Channel Infusion Pumps with recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

pump list number 11971, module list numbers 12101, 12102 and 12393; pump list number 11973, module list number 12380; pump list number 12391, module list numbers 12097 and 12680; all serial numbers

Product
Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake…
Recalling firm
Hospira Inc.
Quantity
N/A
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 Africa, Spain, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates and Vietnam.
Recall date
December 19, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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