—#119808

Product

LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. fluids; Made in Costa Rica; Hospira, Inc., Lake Forest, IL 60045 USA The Hospira Symbiq Infusion System is a general infusion system which provides IV infusion across the general spectrum of clinical care. The Symbiq pumps are standard sized pumps which are typically facility-based infusion pumps which may be used to deliver continuous and/or intermittent infusions to a variety of patient populations.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: List Number: 19666-04-28; Lot Number: 87-188-5H

Why it was recalled

Hospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve. Preliminary investigation findings found that there is a potential for the ball valve to not seal the drip chamber as intended, leading to air in the line of the administration set.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Hospira sent a Urgent Device Recall letter dated June 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were instructed to check their inventories, quarantine any affected products, complete an attached reply form, and return the product to Stericycle for credit using a label included in the mailing. Customers who further distributed the products are requested to forward the recall notification information to their customers. A 100% effectiveness check will be performed for direct Hospira customers who do not return the reply forms and/or the product. Any direct or indirect accounts that return a reply form indicating they have product but do not return it will also be contacted as part of the effectiveness check. In addition, customers who further distributed the product will be requested to provide confirmation that they have notified their customers who purchased the product. Please contact Hospira Customer Care at 1-877-946-7747 ( M-F 7am - 6pm CT) or your Hospira representative regarding replacement product availability and for questions regarding this recall.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) including the states of IA, IL, MN, SD and WA., and Costa Rica.

Timeline

Recall initiated: 2013-06-18
Posted by FDA: 2013-07-18
Terminated: 2016-11-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119808. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.