CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through

FDA device recall Z-2281-2013 · posted 2013-09-26 · Terminated

Recall details

Recalling firm

CareFusion 303, Inc.

Reason for recall

CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.

Action taken

CareFusion sent an Urgent Medical Device Recall Notification letter dated August 30, 2013, to all affected customers to inform them that CareFusion is recalling the Gravity Set, Model 44000-07, Lot Numbers 12086930, 12106215, 13016408, 13016834, 13025446 and 13025672 as a result of an incorrect expiration date. The letter informs the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers are instructed to complete the customer response form and return the form to CareFusion. Customers are instructed to return recalled products directly to distributors. A distributor letter will also be sent to distributors on August 30, 2013, to inform them of the problems identified and the actions to be taken. Distributors are instructed to contact the Customer Support Team, return customer response form, and if they have questions then they are instructed to contact the CareFusion Support Center at 1-800-562-6018. For questions regarding this recall call 858-617-4000.

Root cause

Employee error

Status

Terminated

Product code

FPA

Quantity affected

2,850 units

Distribution

IL

Date initiated

2013-08-30

Date posted

2013-09-26

Date terminated

2013-12-26

Location

San Diego, CA

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