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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-01100-1
Product Name/Description	Stericlin Flat Roll 150mmx200m - 800304 Batch number: 3050168 Lot number: 4046-4145 ARTG 135955 (Med-Con Pty Ltd - Sterilization packaging, single use)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	21/12/2023
Responsible Entity	Med-Con Pty Ltd
Reason/Issue	One of the two sealing side seams are missing over a length of about 25cm. All three grooves of the groove sealing are affected on the above-mentioned length. The incompleteness of the seal is visually recognisable, and the seal seam is open or will open at a very slight stress level. The defective seal is repeating in the affected reels regularly roughly every meter within the roll. The issue will cause the roll to not seal correctly and the product to not sterilize. Resulting in the failure in the sterilization process. Stericlin Flat roll 150mmx200m will not sterilize the instruments resulting in possible contamination. This recall does not affect any other batches/lots/versions of #800304 – Stericlin Flat Roll 150mmx200m or any other Med-con products. This Batch 3050168 – Lot: 4046-4145 has been distributed to hospitals and medical distribution companies from January 2023.
Recall Action	Recall
Recall Action Instructions	Inspect stock immediately and quarantine affected stock with affected batch numbers on hand to prevent further use. Return affected stock on hand to: Store 4/415 New Dookie Rd, Lemnos, VIC 3631 This action has been closed out on 21/3/2024.
Contact Information	03 5822 6600 - Med-Con