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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00565-1
Product Name/Description Jackson-Pratt Perforated and Hemaduct Wound Drainage Systems

Product Codes: JP-HUR101, SU130-1308, SU130-1309, SU130-1310, SU130-1311 and SU130-1411 

Batch Numbers: 1161468, 1161228, 1161396, 1161413, 1161460, 1161461, 1161230, 1161399, 1161247, 1161251, 1161622, 1161623 and 1161253

ARTG Number: 169567
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 3/05/2017
Responsible Entity Medline International Two Australia Pty Ltd
Reason/Issue Medline is recalling specific Jackson-Pratt Perforated and Hemaduct Wound Drainage Systems, due to a potential breach of sterility in the packaging. In a small percentage of product (approximately 1.6%), the inner packaging (polybag) is caught in the seal area of the outer Tyvek pouch, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. To date, the manufacturer has not received any complaints or reports of infection associated with this issue.
Recall Action Recall
Recall Action Instructions Medline is advising customers to remove affected codes/lots from their stock holdings and to also segregate affected units for Medline to collect. Medline will organise pick-up of the affected stock and a credit note will be issued.

This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information 1800 110 511 - Medline Australia Customer Service Team