FDA Device

Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems.

Hazard

The recall was initiated after Advanced Sterilization Products (ASP) discovered a non-conforming lot. The misaligned perforations may have caused the seal to be incomplete on some of the pouches, creating a potential breach for pouches being used to store sterilized equipment on shelves.

What You Should Do

Remedy

Advanced Sterilization Products (ASP) released Urgent: Product Recall notifications to its consignees identifying the affected product and explaining the reason for recall. The letter also discussed the impact of using this affected product and return instructions. The firm asked customers to examine their inventory, discontinue use of Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332 and to return all unused affected products to Stericycle. Customers are to complete the Business Reply Card and return it to Stericycle.

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Products

Tyvek Self-Seal Pouch with STERRAD Chemical Indicator 12332. Intended to be used to contain medical devices that are being terminally sterilized in STERRAD Sterilization Systems.
UPC
Lot Number: 2020

Units Affected

470

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