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Protector 21, Protector 50, Protector 14, Injector Luer Lock, Infusion Adapter

by Carmel Pharma Ab.

510(k) K001368

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK001368 Date12 May 2000ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-1181-2007 FDA Unclassified (pre-2012) initiated 26 Jun 2007 on shared 510(k) K001368
    • Terminated Z-1179-2007 FDA Unclassified (pre-2012) initiated 26 Jun 2007 on shared 510(k) K001368
    • Terminated Z-1180-2007 FDA Unclassified (pre-2012) initiated 26 Jun 2007 on shared 510(k) K001368
    • Terminated Z-1178-2007 FDA Unclassified (pre-2012) initiated 26 Jun 2007 on shared 510(k) K001368

    Risk of Leakage: When the PhaSeal Protector and Injector are used with drug vials with thick rubber stoppers which have a concave upper surface and a flat bottom surface there is a potential for leakage. These rubber stoppers are made of a harder rubber formulation and may be more difficult to penetrate.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LHI
Device Class
Class II
Regulation
21 CFR Part 880.5440
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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