Recall Z-2874-2016 ยท MEA Pump, Infusion, Pca
Hospira Inc.
LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.
| Date | Mar 8, 2013 |
| Status | Terminated |
| Reason | Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops. |
| Root cause | Nonconforming Material/Component |
| Action | Hospira will contract with Stericycle, Inc. in Indianapolis, IN to send letter and a reply form to Hospira, Inc. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating the number of pumps on hand and that they have received the letter and notified their users. In addition, letters will be sent by email to ECRI, NRAC, Noblis and ISMP for notification of their members and posting on their websites. The letter will also be posted to the Hospira website. Letters will be sent to Hospira customers of record who purchase |
| Quantity | 69 |
| Distribution | United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042800 | LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE Hospira, Inc., Oct 18, 2004 |