Device 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.
Z-1751-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 65647
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,400 units
- Official record key
device-enforcement:Z-1751-2013
Official wording
Reason: 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.
Code information: List Number: 19666-04-28; Lot Number: 87-188-5H
Distribution pattern: Worldwide Distribution - US (nationwide) including the states of IA, IL, MN, SD and WA., and Costa Rica.
Derived failure modes
-
Unknown
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.