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PST Corp.

Tray Plastic Sterilizing Corporation Inc · Model 2700M · UDI-DI 00810051830255

FSM
10
510(k) clearances
2,357
Adverse events (2 deaths)
40
Recalls
876
Facilities

Description

Silicone Mat Only

Recalls

DateFirmReason
2026-09-16Howmedica Osteonics Corp.Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m
2026-09-16Howmedica Osteonics Corp.Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m
2026-09-16Howmedica Osteonics Corp.Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m
2026-09-16Howmedica Osteonics Corp.Reprocessing instructions provided in LSTPI-B specify a sterilization dry time of 30 minutes for the trays sterilized in blue wrap. When blue wrap is used, the 30-minute dry time m
2025-07-18Encore Medical, LPTheir is a potential that the reamer may kick or bind up during or immediately prior to use.
2024-06-11Medical Action Industries, Inc. 306The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foa
2024-04-08MEDLINE INDUSTRIES, LP - NorthfieldMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2023-11-15MEDLINE INDUSTRIES, LP - NorthfieldMedline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile
2023-02-23Aesculap Implant Systems LLCMislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
2022-12-15Stradis HealthcarePotential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

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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.