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Picc Convenience Kit

by Navilyst Medical, Inc.

510(k) K121990

Picc Convenience Kit is a Class II device made by Navilyst Medical, Inc., cleared under FDA 510(k) K121990 on 3 Aug 2012, active as of 22 Oct 2026. 17 FDA recalls are linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

17 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK121990 Date3 Aug 2012ClearedStatusActive

Official records

Recalls

17 recalls · FDA

    • Terminated Z-0596-2019 FDA Class II initiated 16 Oct 2018

    specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date.

  • 4 recalls, same reason

    • Terminated Z-2201-2018 FDA Class II initiated 10 May 2018
    • Terminated Z-2200-2018 FDA Class II initiated 10 May 2018
    • Terminated Z-2213-2018 FDA Class II initiated 10 May 2018
    • Terminated Z-2216-2018 FDA Class II initiated 10 May 2018

    A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

  • 12 recalls, same reason

    • Terminated Z-0035-2015 FDA Class II initiated 25 Aug 2014
    • Terminated Z-0025-2015 FDA Class II initiated 25 Aug 2014
    • Terminated Z-0027-2015 FDA Class II initiated 25 Aug 2014
    • Terminated Z-0028-2015 FDA Class II initiated 25 Aug 2014
    • Terminated Z-0033-2015 FDA Class II initiated 25 Aug 2014
    • Terminated Z-0030-2015 FDA Class II initiated 25 Aug 2014
    • Terminated Z-0036-2015 FDA Class II initiated 25 Aug 2014
    • Terminated Z-0031-2015 FDA Class II initiated 25 Aug 2014
    • Terminated Z-0032-2015 FDA Class II initiated 25 Aug 2014
    • Terminated Z-0026-2015 FDA Class II initiated 25 Aug 2014
    • Terminated Z-0034-2015 FDA Class II initiated 25 Aug 2014
    • Terminated Z-0029-2015 FDA Class II initiated 25 Aug 2014

    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.

Timeline

18 dated events

  1. Recall initiated FDA recalls Z-0031-2015
  2. Recall initiated FDA recalls Z-0032-2015
  3. Recall initiated FDA recalls Z-0026-2015
  4. Recall initiated FDA recalls Z-0034-2015
  5. Recall initiated FDA recalls Z-0029-2015
  6. Recall initiated FDA recalls Z-2201-2018
  7. Recall initiated FDA recalls Z-2200-2018
  8. Recall initiated FDA recalls Z-2213-2018
  9. Recall initiated FDA recalls Z-2216-2018
  10. Recall initiated FDA recalls Z-0596-2019

8 earlier events are in the sections above.

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
LJS
Device class
Class II
Regulation
21 CFR Part 880.5970
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Similar devices

Other devices filed under FDA product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days).

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