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Rejoni Intrauterine Catheter

Rejoni, Inc. · Model CA-2015 · UDI-DI 00860010540909

LKF Prescription

510(k) clearances

1,788

Adverse events (2 deaths)

Recalls

102

Facilities

Description

The Rejoni Intrauterine Catheter is for the delivery of contrast media or saline into the uterine cavity during Hysterosalpingography (HSG) or Sonohysterography (SHG) for examination of the uterus and fallopian tubes. When used for HSG, the Rejoni Intrauterine Catheter can be used for evaluation of tubal patency. The Rejoni Intrauterine Catheter is used to access the uterine cavity for the delivery of saline for Sonohysterography (SHG).

Recalls

Date	Firm	Reason
2022-05-25	Mckesson Medical-Surgical Inc. Corporate Office	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2022-03-31	CooperSurgical, Inc.	Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay
2022-03-31	CooperSurgical, Inc.	Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay
2022-03-31	CooperSurgical, Inc.	Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay
2019-05-30	Clinical Innovations, LLC	An incorrect component used during manufacturing. The uterine manipulator tip support does not have the "notch" required to attach the spacer and or colpotomy cup. This may result
2015-05-18	CooperSurgical, Inc.	Design of device may expose user to injury to fingers or body parts
2014-07-03	CooperSurgical, Inc.	Unsealed pouches.
2014-05-13	CooperSurgical, Inc.	Sterility of the device may be compromised due to unsealed pouch
2012-10-31	Cooper Surgical, Inc.	Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning
2012-10-31	Cooper Surgical, Inc.	Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.