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0.9% Sodium Chloride Injection, Usp Bd Postflush Sf Flush Syringe

by Becton Dickinson

510(k) K042061

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

13 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 NumberK042061 Date26 Aug 2004ClearedStatusActive

Recalls

13 recalls · FDA

  • 12 recalls, same reason

    • Terminated Z-0028-2015 FDA Class II initiated 25 Aug 2014 on shared 510(k) K042061
    • Terminated Z-0032-2015 FDA Class II initiated 25 Aug 2014 on shared 510(k) K042061
    • Terminated Z-0026-2015 FDA Class II initiated 25 Aug 2014 on shared 510(k) K042061
    • Terminated Z-0034-2015 FDA Class II initiated 25 Aug 2014 on shared 510(k) K042061
    • Terminated Z-0029-2015 FDA Class II initiated 25 Aug 2014 on shared 510(k) K042061
    • Terminated Z-0035-2015 FDA Class II initiated 25 Aug 2014 on shared 510(k) K042061
    • Terminated Z-0025-2015 FDA Class II initiated 25 Aug 2014 on shared 510(k) K042061
    • Terminated Z-0027-2015 FDA Class II initiated 25 Aug 2014 on shared 510(k) K042061
    • Terminated Z-0031-2015 FDA Class II initiated 25 Aug 2014 on shared 510(k) K042061
    • Terminated Z-0033-2015 FDA Class II initiated 25 Aug 2014 on shared 510(k) K042061
    • Terminated Z-0030-2015 FDA Class II initiated 25 Aug 2014 on shared 510(k) K042061
    • Terminated Z-0036-2015 FDA Class II initiated 25 Aug 2014 on shared 510(k) K042061

    NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.

    • Terminated Z-2670-2014 FDA Class II initiated 25 Jul 2014

    Unit packages may exhibit open seals which impacts package integrity and potentially product sterility.

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
NGT
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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