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U.S. Department of Health and Human Services

Class 2 Device Recall LifeShield Symbiq Set

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 Class 2 Recall
LifeShield Symbiq Set
see related information
Date Posted July 18, 2013
Recall Status1 Open
Recall Number Z-1751-2013
Recall Event ID 65647
Premarket Notification
510(K) Number
K110901 
Product Classification Set, Administration, Intravascular - Product Code FPA
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.
Code Information List Number: 19666-04-28; Lot Number: 87-188-5H
Recalling Firm/
Manufacturer
Hospira Inc.
275 N Field Dr
Lake Forest, Illinois 60045-2579
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action 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.
Quantity in Commerce 14,400 units
Distribution Worldwide Distribution - US (nationwide) including the states of IA, IL, MN, SD and WA., and Costa Rica.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = HOSPIRA, INC.
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