Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged, product code: 340-4166, Method of Sterilizatio

FDA device recall Z-1669-2012 · posted 2012-05-30 · Terminated

Recall details

Recalling firm

MOOG Medical Devices Group

Reason for recall

Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.

Action taken

The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: lbrewer@moog.com.

Root cause

Process design

Status

Terminated

Product code

FPK

Quantity affected

7,900 sets.

Distribution

Nationwide distribution: USA including states of: AZ, CA, FL, IL, KS, MA, MI, MD, NC, ND, NY, OK, OH, and TX.

Date initiated

2012-05-18

Date posted

2012-05-30

Date terminated

2013-02-22

Location

Salt Lake City, UT

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