***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 3

FDA device recall Z-0072-2013 · posted 2012-10-17 · Terminated

Recall details

Recalling firm

MOOG Medical Devices Group

Reason for recall

This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used with Curlin Ambulatory Infusion Pumps. The lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by

Action taken

MOOG sent a Medical Device Recall Notification letter dated September 26, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove product from their inventory and return to the firm. Customers were also instructed to contact their distributor to arrange for replacement product. For questions customers were instructed to call 1-800-970-2337, prompt #7. For questions regarding this recall call 801-264-1001.

Root cause

Process control

Status

Terminated

Product code

FRN

Quantity affected

12,000 sets

Distribution

Nationwide Distribution including California

Date initiated

2012-09-26

Date posted

2012-10-17

Date terminated

2013-04-05

Location

Salt Lake City, UT

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