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U.S. Department of Health and Human Services

Class 1 Device Recall 900MR068 Reusable Circuits

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 Class 1 Recall
900MR068 Reusable Circuits
see related information
Date Posted January 03, 2013
Recall Status1 Terminated on July 11, 2013
Recall Number Z-0621-2013
Recall Event ID 63794
Product Classification Set, Tubing And Support, Ventilator (W Harness) - Product Code BZO
Product Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Code Information Lots 110810 and 111020
Recalling Firm/
Manufacturer
Fisher & Paykel Healthcare, Ltd.
15 Marcel Place
East Tamaki
North Shore City
For Additional Information Contact Derek Arndt
949-4434095
Manufacturer Reason
for Recall
FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Fisher & Paykel sent an Urgent Medical Device Recall letter dated November 19, 2012, with a Product Recall Response Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to destroy and discard any affected circuits in their possession. Customers were instructed to complete and return the Product Recall Response form to the address indicated on the form, even if they have no affected product. Customers were asked to forward the recall notice to all those who need to be aware within their organization. Customers with questions should call 1-800-792-3912. For questions regarding this recall call 949-443-4095.
Quantity in Commerce 200 units total, 26 units US
Distribution Worldwide Distribution - USA including IL, IN, AR and GA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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