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Tyvek™ Self-Seal Pouch

CROSSTEX INTERNATIONAL, INC. · Model TSP-181 · UDI-DI 10732224009015

FRG

510(k) clearances

222

Adverse events

Recalls

194

Facilities

Description

Tyvek™ Self-Seal Pouch, 3.5"× 9"/ 9×23cm

Recalls

Date	Firm	Reason
2022-12-05	Turbett Surgical, Inc.	Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
2022-12-05	Turbett Surgical, Inc.	Pod may have weld failures breaching the sterile barrier and result in the use of unsterile instruments leading to infection or other major injuries.
2022-04-14	Turbett Surgical, Inc.	Devices were subject to unapproved rework processes.
2022-04-01	TURBETT SURGICAL, LLC	Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.
2020-12-02	Steris Corporation	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some inst
2020-12-02	Steris Corporation	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some inst
2020-12-02	Steris Corporation	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some inst
2020-12-02	Steris Corporation	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some inst
2020-12-02	Steris Corporation	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some inst
2020-12-02	Steris Corporation	Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some inst

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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.