Z-1751-2013Class II

LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS...

Name: Z-1751-2013 LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS...
Creator: Hospira Inc.
Published: 2013-06-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-06-18 / Terminated

FDA source

Hospira Inc. began a recall of 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... on 2013-06-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1751-2013
Classification: Class II
Status: Terminated
Initiated: 2013-06-18
Posted: 2013-07-18
Terminated: 2016-11-07
Recalling firm: Abbott Medical
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.
Product code: FPA Set, Administration, Intravascular
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 root cause: Under Investigation by 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.
Product codes and lots: List Number: 19666-04-28; Lot Number: 87-188-5H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1751-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1751-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-18

Product code FPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)