Home › Plasmapp Co.,Ltd. › STERLINK™

STERLINK™

Plasmapp Co.,Ltd. · Model FR400100 · UDI-DI 08800066500214

JOJ FRG

510(k) clearances

392

Adverse events (1 deaths)

Recalls

129

Facilities

Description

Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices for up to 1 month post sterilization.

Recalls

Date	Firm	Reason
2023-12-07	TERRAGENE S.A.	Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products.
2023-04-06	3M Company - Health Care Business	3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.
2023-04-06	3M Company - Health Care Business	3M Attest Steam Chemical Integrators with dates of manufacture between November 6, 2022 and January 17, 2023 have an increased potential to leak ink during a sterilization cycle.
2022-08-10	Steris Corporation Hopkins Facility	Product contains incorrect chemical indicators in packaging.
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2021-12-29	Young Dental Mfg Co I LLC	The Dry Heat Indicator Labels packaging may contain TTS Indicator Labels instead of Dry Heat Indicator Labels.
2020-06-17	Resource Optimization & Innovation LLC	The firm received reports from customer that the Regard Migrating Indicator shown malfunctions and does not go into the "accept" window at the time of use.
2013-12-19	Steris Corporation	STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A.
2013-06-10	Steritec Products Mfc. Co., Inc.	Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout t

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.