Device Recall Infusion Administration Set 의 리콜

Recall

57829

Class 2

Z-1441-2011

2011-01-24

2011-02-25

Terminated

United States

2011-09-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97521

Defect in tubing may trigger false air-in-line warning.

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.