Z-1751-2013 Class II Terminated
FDA device recall Z-1751-2013 was initiated by Hospira Inc. on Jun 18, 2013 and is designated Class II. 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… The recall status is terminated (terminated Nov 7, 2016). Affected quantity: 14,400 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 24, 2013
- Initiation Date
- Jun 18, 2013
- Termination Date
- Nov 7, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,400 units
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution - US (nationwide) including the states of IA, IL, MN, SD and WA., and Costa Rica.
Code Information
List Number: 19666-04-28; Lot Number: 87-188-5H
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1751-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026