Recall Z-0837-2022— ROi CPS LLC

Name: FDA recall Z-0837-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-24

Class III · Terminated

Class III FDA medical device recall by ROi CPS LLC, initiated 2022-02-24, terminated 2022-04-25. It names one FDA 510(k) clearance: K991088. Product: Regard Custom Procedure Kits containing BD Luer Lok Access Devices. Reason: Recalled devices were packaged in convenience kits..

Recalling firm: ROi CPS LLC
Classification: Class III
Status: Terminated
Initiated: 2022-02-24
Terminated: 2022-04-25
Firm location: Republic, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K991088 — VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLEBecton Dickinson Vacutainer Systems·cleared 1999-05-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Regard Custom Procedure Kits containing BD Luer Lok Access Devices

Reason for recall

Recalled devices were packaged in convenience kits.

Data sourced from openFDA. This site is unofficial and independent of the FDA.