—#148422

Product

LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.

FDA product code: MEA — Pump, Infusion, Pca
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K042800
Affected lot / code info: Serial Number 12921204 12922976 12924008 12925861 12925924 12925998 12928528 12928807 12929016 12929126 12920432 12920820 12920856 12920915 12921404 12921413 12922304 12922976 12925861 12925998 12927215 12929016 12931044 12931141 12931155 12931192 12931244 12931342 12931361 12931413 12931610 12931639 12931649 12931911 12921480 12921487 12923723 12924326 12924350 12924546 12925259 12925447 12926315 12927938 12928075 12928614 12930418 12930709 12930890 12931441 12931760 12931911 12932487 12932717 12920754 12920791 12920897 12921063 12921613 12922062 12923441 12924161 12926859 12927756 12928775 12929346 12929438 12931942 12920112

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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 purchased the devices directly from Hospira. Customers will be directed to notify their consignees if they further distributed the product and confirm they have done so. Telephone attempts will be made to contact customers that do not respond in order to confirm receipt of the letter. Final effectiveness will be done as the devices are upgraded with new plastic motors.

Recalling firm

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

Distribution

Distribution pattern: United States (Nationwide) Distribution including Puerto Rico and American Virgin Islands.

Timeline

Recall initiated: 2013-03-08
Terminated: 2016-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148422. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.