Recall Z-1250-2022— ROi CPS LLC

Name: FDA recall Z-1250-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-03

Class II · Terminated

Class II FDA medical device recall by ROi CPS LLC, initiated 2022-05-03, terminated 2024-05-31. It names one FDA 510(k) clearance: K952204. Product: Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm. Reason: Potential for the tip of the electrode to detach during use..

Recalling firm: ROi CPS LLC
Classification: Class II
Status: Terminated
Initiated: 2022-05-03
Terminated: 2024-05-31
Firm location: Republic, MO, United States

510(k) clearances named in this recall

1 on FDA's record

K952204 — CONMED/ASPEN LABS COATED LAPAROSCOPIC ELECTROSURGICAL BLADESConmedcorp·cleared 1995-05-25

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 Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm

Reason for recall

Potential for the tip of the electrode to detach during use.

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