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HCT Empty EVA Container Pack

by Health Care Technologies 510(k)

Active United States Open recall

510(k) K190328

Regulatory status

as of 29 Oct 2026

Recall ongoing. 2 ongoing FDA recalls name this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190328 Date15 Aug 2019ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0936-2023 FDA Class II initiated 15 Dec 2022
    • Ongoing Z-0937-2023 FDA Class II initiated 15 Dec 2022

    Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Specification

510(k)

510(k) Number
FDA Product Code
KPE
Device Class
Class II
Regulation
21 CFR Part 880.5025
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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