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

FDA device recall Z-1751-2013 · posted 2013-07-18 · Terminated

Recall details

Recalling firm

Hospira Inc.

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

FPA

Quantity affected

14,400 units

Distribution

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

Date initiated

2013-06-18

Date posted

2013-07-18

Date terminated

2016-11-07

Location

Lake Forest, IL