GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device design

FDA device recall Z-1160-2013 · posted 2013-04-26 · Terminated

Recall details

Recalling firm

Hospira Inc.

Reason for recall

Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.

Action taken

Hospira sent an Urgent Device Field Correction letter dated March 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify their consignees if they further distributed the product and confirm they have done so by return of the reply form to Stericycle. Lithium batteries that are older than three (3) years should be replaced. Customers should contact their Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, to determine if their battery need to be replaced and if necessary, arrange for the return of their device to perform battery replacement. Customers with questions should call 1-877-907-7516. For questions regarding this recall call 224-212-4892.

Root cause

Device Design

Status

Terminated

Product code

FRN

Quantity affected

List Number 13086: 286 pumps; List Number 13087: 45,376 pumps; List Number 13088: 23,492 pumps

Distribution

Worldwide Distribution - USA (nationwide) Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, F

Date initiated

2013-03-18

Date posted

2013-04-26

Date terminated

2017-03-07

Location

Lake Forest, IL

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