The Recall Desk
HighFDA (Devices)·Z-1250-2022·Announced 2022-06-15

Surgical needle electrode tip detachment risk during gastroenterology procedures

ROi CPS LLC is recalling a sterile surgical needle used in gastroenterology bypass procedures because the electrode tip may detach during use. The recall affects 125 units distributed in North Carolina.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a surgical device with potential for electrode tip detachment during use, creating risk of retained foreign body or device malfunction. No injuries or illnesses have been reported, which classifies this as High rather than Severe per the rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ROi CPS LLC is recalling a sterile surgical needle (Catalog No. 60-5274-944, Item Number 800214007, Model GS00367) used in gastroenterology bypass procedures. The needle is approximately 44 centimeters long with a 5-millimeter electrode. The recall was initiated because the electrode tip has the potential to detach during use, which could result in patient injury or loss of device functionality during the procedure.

The recall affects 125 units distributed to medical facilities in North Carolina. The affected lot numbers are 88207G (expiration 05/11/2023), 88396G (expiration 05/26/2023), 88472G (expiration 06/02/2023), 88965G (expiration 07/02/2023), and 91105 (expiration 01/07/2024).

Healthcare providers with affected units in stock should discontinue use immediately. Contact ROi CPS LLC or the U.S. Food and Drug Administration for instructions regarding device return, replacement, or destruction. Patients who may have been treated with this device should consult their healthcare provider if they experience any concerning symptoms.

The recalled product

Product
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
Manufacturer
ROi CPS LLC
Category
Medical Device — Surgical Needle / Gastroenterology
Hazard
  • electrode-detachment
  • retained-foreign-body

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Catalog No. 60-5274-944
  • Item Number: 800214007
  • Model Number: GS00367G
  • UDI/DI: 10194717101024
  • Lot Numbers: 88207G (Exp. Date: 05/11/2023)
  • 88396G (Exp. Date: 05/26/2023)
  • 88472G (Exp. Date: 06/02/2023)
  • 88965G (Exp. Date: 07/02/2023)
  • 91105 (Exp. Date: 01/07/2024)

Distribution

Distribution scope not specified by the agency.

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