Level 1 Normothermic I.V. Fluid Administration Set REF DI-60HL (Foreign Distribution Only)

FDA device recall Z-0251-2007 · posted 2006-12-06 · Terminated

Recall details

Recalling firm

Smiths Medical ASD, Inc.

Reason for recall

IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming.

Action taken

Smiths Medical ASD notified Direct customers and distributors via letter sent by UPS on or about November 6, 2006 and the days following as necessary until all consignees are notified. Letters to direct customers will be addressed to the Risk Manager. All Smiths Medical affiliates contacted by e-mail and given instructions to send a letter to their customers and to confirm to Smiths Medical that their customers have taken appropriate action by returning the affected product. US Distributors instructed to return the affected product and to provide a customer list. Foreign distributors instructed to return the affected product and given instructions to send a letter to their customers and to confirm to Smiths Medical that their customers have taken appropriate action by returning the affected product.

Root cause

Equipment maintenance

Status

Terminated

Product code

FPA

Quantity affected

13,640 units

Distribution

Worldwide, including USA, Japan, Canada, Ireland, UK, Finland, Netherlands, Germany, Austria, Portugal, France, Sweden, Australia, New Zealand, Russia, Italy, Singapore, Kuwait, Saudi Arabia, Czech Re

Date initiated

2006-11-07

Date posted

2006-12-06

Date terminated

2009-11-30

Location

Rockland, MA