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Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00490-1
Product Name/Description	TB2000 Disposable t-piece infant resuscitation circuit with adjustable PEEP This Recall:- Batch / Lot Number: TB2000-0146, TB2000-0149 and TB2000-0151 Previous Recall from December 2016:- Batch / Lot Number: TB2000-0141 ARTG Number: 188097
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	19/04/2017
Responsible Entity	Swirl Technologies Pty Ltd T/A Parker Healthcare
Reason/Issue	During an investigation of the reported customer complaints, the manufacturer has identified that there is a potential for some circuits of the affected batches to operate incorrectly. The 10mm Female connector was slightly oversized during its manufacturing and therefore the device could become loose from the Fisher & Paykel NeoPuff’s 10mm Male connector under certain conditions and would therefore not deliver the required pressure to the patient.
Recall Action	Recall
Recall Action Instructions	Affected Lots are being recalled from Hospitals. Users are requested to note this is an expanded recall from December 2016 where this issue was first identified and Batch Number: TB2000-0141 was recalled. This action has been closed out on 29/10/2018
Contact Information	03 9872 0222 - Parker Healthcare