Skip to content

Primary Care Solutions Prefilled 10cc and Prefilled 30cc Inflation Syringes with Sterile Water Catalog Numbers 1010 and

by Primary Care Solutions, Inc.

510(k) K030813

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 · Traditional NumberK030813 Date30 May 2003ClearedStatusActive

Recalls

27 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0515-2024 FDA Class I initiated 6 Nov 2023
    • Ongoing Z-0511-2024 FDA Class I initiated 6 Nov 2023 on shared 510(k) K030813

    Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.

  • 25 recalls, same reason

    • Terminated Z-1223-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1218-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1227-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1209-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1224-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1210-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1206-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1214-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1226-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1229-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1220-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1212-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1221-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1211-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1215-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1208-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1222-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1203-2016 FDA Class II initiated 22 Jan 2016 on shared 510(k) K030813
    • Terminated Z-1213-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1205-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1225-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1216-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1217-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1228-2016 FDA Class II initiated 22 Jan 2016
    • Terminated Z-1219-2016 FDA Class II initiated 22 Jan 2016

    Aplicare Castile Soap towelettes included in the Foley Trays and Mid stream specimen kits are contaminated with bacteria

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
EZL
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Primary Care Solutions, Inc.