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Invenio

GRI Medical & Electronic Technology Co., Ltd. · Model TBC003 · UDI-DI 16931918171470

PXI
0
510(k) clearances
168
Adverse events (1 deaths)
19
Recalls
21
Facilities

Description

Breast Pack_Sterile_4EA/CS

Recalls

DateFirmReason
2026-05-21Bard Access Systems, Inc.Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
2026-05-21Bard Access Systems, Inc.Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
2026-05-21Bard Access Systems, Inc.Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
2025-11-06Bard Peripheral Vascular IncAcute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in shar
2022-04-22Bard Peripheral Vascular IncThere is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Uni
2020-05-28Carefusion 2200 IncThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
2020-05-28Carefusion 2200 IncThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
2020-05-28Carefusion 2200 IncThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
2020-05-28Carefusion 2200 IncThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
2020-05-28Carefusion 2200 IncThe Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.

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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.