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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-01262-1
Product Name/Description Viscocel and Viscocel Plus (Hydomethylpropcellulose) 2% Prefilled Syringes 1.5mL and 2.0mL

Product Codes: AusVIS15, AusVIS20

Batch Numbers: 13D02 (expiry 04/2015), 12A13 (expiry 01/2015), 12J08 (expiry 10/2014), 13B18 (expiry 02/2015), 12J02 (expiry 10/2014), 12G16 (expiry 07/2014), 12I04 (expiry 09/2014) and 12H20 (expiry 08/2014)

Manufactured from September 01, 2011 to September 19, 2013

ARTG Number: 132648
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 6/12/2013
Responsible Entity Boucher & Muir Pty Ltd
Reason/Issue Inspections findings by the FDA noted deficiencies in the quality system regulations for medical device manufacturers relating to sterility and biocompatibility that may result in the release of contaminated products. No injuries have been reported for ViscoCel, however several cases of endophthalmitis reported to a related viscoelastic product in 2011 manufactured at the same facilities.
Recall Action Recall
Recall Action Instructions Boucher & Muir is advising users to quarantine all units of the affected batches. Boucher & Muir is recovering affected stock and a credit note issued.
Contact Information 1800 627 680 - Boucher & Muir