—#114747

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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K011442, K042081, K070398, K982159
Affected lot / code info: list numbers 11971, 11973, 12391, 20679, and 20792; all serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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..

Recalling firm

Firm: Hospira Inc.
Address: 275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern: 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, Slovenia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United Arab Emirates, and Vietnam.

Timeline

Recall initiated: 2012-12-07
Posted by FDA: 2012-12-31
Terminated: 2016-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114747. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.