Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pre

FDA device recall Z-2776-2015 · posted 2015-09-16 · Terminated

Recall details

Recalling firm

Edward Lifesciences, Llc

Reason for recall

Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw.

Action taken

Edwards sent an Urgent Product Recall Letter on August 10, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm's letter requests that customers return any of the units that they currently have in inventory. The letter requests that customers verify the inventory that has been pre-populated on the acknowledgment form, and complete the remainder of the form. The firm states to fax back the acknowledgment form within three days of receipt of notification to Edwards Customer Service at 1-800-422-9329. The firm requests to call Edwards Customer Service at 1-800-424-3278 to arrange for return of any unused product from the implicated lots as well as to obtain information about product replacment. The notification states to call for an RGA prior to returning any unused product and return unused product to the firm at Edwards Lifesciences Return Goods. Any questions the firm states to contact Edwards Customer Service at 1-800-424-3278.

Root cause

Device Design

Status

Terminated

Product code

DXO

Quantity affected

13,077 (U.S.) and 12,306 (International)

Distribution

Worldwide Distribution - US nationwide, Australia, Austria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Great Britain, Italy, Netherlands, New Zealand, Sweden, and Slovenia.

Date initiated

2015-07-31

Date posted

2015-09-16

Date terminated

2016-07-08

Location

Irvine, CA

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