Recall Z-0624-2013
Hospira Inc. · initiated December 7, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
Codes / lots: list numbers 11971, 11973, 12391, 20679, and 20792; all serial numbers
Reason for recall
The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump.
FDA-determined cause: Device Design
Action taken
Hospira Inc. sent "URGENT DEVICE FIELD CORRECTION" letters, dated December 7, 2012, to all affected customers. The letters identified the products, problem and action(s) to be taken until doors have been replaced. The customers were instructed to read the information provided carefully, including instructions to inspect the door roller assembly prior to loading a cassette for signs of damage. Customers are to complete the attached Reply Form and return it to the firm via fax at 1-877-650-8359. Customers were instructed to notify their consignees if they have further distributed the affected product. If customers require additional assistance, they are to contact Stericycle at 1-877-650-0362..
Details
- Recall number
- Z-0624-2013
- Initiated
- December 7, 2012
- Posted by FDA
- December 31, 2012
- Terminated
- November 14, 2016
- Product code
- FRN – Pump, Infusion
- Quantity
- 297,833 units
- Distribution
- Worldwide Distribution -- USA, including Puerto Rico, and the countries of Austria, Australia, Argentina, Bahrain, Belgium, Brazil, Canada, Chile, Colombia, Denmark, Finland, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore…
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0625-2013 Class II | Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps…The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can… | 12/07/2012Terminated |
| Z-0626-2013 Class II | Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045…The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can… | 12/07/2012Terminated |