HIGH
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect
HIGH
Iantrek Recalls C-Rex UNO Goniotomy Instrument Over Sterility Risk
Iantrek recalled 198 C-Rex UNO Microinterventional Goniotomy Instruments on September 6, 2025, due to compromised sterile packaging. The recall affects the model CRX-120 distributed in multiple U.S. states. Healthcare providers and patients must stop using these instruments immediately.
Quick Facts at a Glance
- Recall Date
- September 6, 2025
- Hazard Level
- HIGH
- Brand
- Iantrek
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
Hazard Information
Potential for compromised integrity of the sterile packaging.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Iantrek Inc. or your healthcare provider for instructions. Notification method: E-Mail
Product Details
The recalled product is the C-Rex UNO Microinterventional Goniotomy Instrument, model number CRX-120. It is a sterile single-use manual surgical instrument used for ophthalmic procedures. The devices were distributed nationwide in states including California, Texas, and New York.
The Hazard
The recall stems from a potential compromise in the integrity of the sterile packaging. This issue can lead to contamination and risk of infection during surgical procedures.
Reported Incidents
As of now, there have been no reported injuries or incidents associated with the compromised instruments. The high hazard level of this recall indicates a serious risk to patient safety.
What to Do
Patients and healthcare providers should stop using the recalled instruments immediately. Contact Iantrek Inc. or your healthcare provider for further instructions regarding the recall.
Contact Information
For more information, contact Iantrek Inc. via email. Visit the FDA's recall page for additional details.
Key Facts
- Recall Date: September 6, 2025
- Model Number: CRX-120
- Quantity Recalled: 198
- Distribution: Nationwide in multiple states
- Class II Medical Device
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeSurgical Instrument
Sold At
Multiple Retailers
Product Details
Brand
Categories
Model Numbers
1. Model Number: CRX-120
UDI: +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$
Lot Number 351729
Exp date 05/2026. 2. Model Number: CRX-120 UDI: +B962CRX1200/$$7351759/16D20250501/14D20260501/Q1%
Lot Number: 351759
+1 more
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
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CGMP Deviations:
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Labeling: Incorrect or Missing Lot and/or Exp Date
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