Recall Z-1833-2016
Hospira Inc. · initiated March 25, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories. Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), and optional accessories. The Plum A+ host device contains a Connectivity Engine peripheral module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira Mednet networked application software to download drug libraries to the infuser and enable the autoprogramming feature.
Codes / lots: PLum A+ devices with the following list numbers: 12391-04-25, 12391-22-05, 12391-23-05, 12391-23-15, 12391-36-07, 12391-54-05, 12391-88-01, 12391-88-02, 12391-88-03, 12391-88-04, 12391-88-05, 20792-04-25, 20792-13-09, 20792-57-15, 20792-65-01, 20792-65-02 and 20792-88-69.
Reason for recall
Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.
FDA-determined cause: Process control
Action taken
Hospira Inc, sent an "URGENT MEDICAL DEVICE CORRECTION" letter on March 31, 2016, to the direct consignees of record via traceable mailing which included a data capture log containing a list of devices located with each customer. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. Please take the following actions related to Urgent Medical Device Correction letter notification: 1. Inform potential users in your organization of this notification. 2. Complete the attached reply form and return it to the fax number or e-mail address on the form, even if you do not have the affected product. 3. If you have distributed the product further, notify your accounts that received the product identified above of this notification and ask them to contact Stericycle at 1-877-479-8088 (M-F, 8am-5pm ET) to receive a reply form. Hospira will contact you to make arrangements for your impacted Plum 360 I Plum A+ devices to be re-calibrated to correct this issue. :
Details
- Recall number
- Z-1833-2016
- Initiated
- March 25, 2016
- Terminated
- March 6, 2018
- Product code
- FRN – Pump, Infusion
- Quantity
- 2567 Plum A+ infusion pumps.
- Distribution
- U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.
- Recalling firm
- Hospira Inc., Lake Forest, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1832-2016 Class II | The Plum 360 is a large volume infuser capable of delivering fluids for a variety of…Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to… | 03/25/2016Terminated |