Curlin Infusion Administration Set, REF 340-4134, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 8412

FDA device recall Z-1448-2011 · posted 2011-02-25 · Terminated

Recall details

Recalling firm

Zevex International, Inc.

Reason for recall

Defect in tubing may trigger false Air-In-Line warning.

Action taken

The firm, MOOG, sent an "Expansion of Moog/Curlin Ambulatory Pump Administration Set Recall" letter dated May 2, 2011 to its customers. This letter informed the customers that this recall has been expanded to included specific lot numbers of Curlin model ambulatory infusion administration sets. The customers were instructed to follow the outlined process in the letter: remove suspect product code from inventory, contact MOOG Customer Service at 1-800-970-2337, prompt #7, contact your distributor to arrange replacement product, request a shipping return label as per the distributor's process and ship back to their location and follow the temporary solution outlined in the letter. Moog Customer Service will provide a call tag for convenient product return. If you have any questions contact MOOG Customer Service at 1-800-970-2337. The firm, MOOG, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 24, 2011 to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to remove suspect product code from inventory; contact their distributor to arrange replacement product, if purchased from distributor and request shipping return label per distributors process and ship back to their location or contact MOOG Customer Service at 800-970-2337, prompt #7, if purchased directly from MOOG and MOOG Customer Service will provide a call tag for convenient product return; follow the temporary solution provided until replacements are administered; and complete and return the MEDICAL DEVICE CORRECTION REPLY FORM in the self addressed envelope provided. If you have any questions, contact MOOG Customer Service at 800-970-2337.

Root cause

Process control

Status

Terminated

Product code

FRN

Quantity affected

51,400 units (US), 1600 units (INTL)

Distribution

Worldwide Distribution: USA including states of: AR, CA, FL, IA, KS, MS, NE, NY, OH, OK, TN, TX, and UT; and countries including: Australia, Croatia, France, Germany, Kuwait, New Zealand, Qatar, Saudi

Date initiated

2011-01-24

Date posted

2011-02-25

Date terminated

2011-09-27

Location

Salt Lake City, UT

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