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
B BRAUN MEDICAL Recalls Epidural Anesthesia Set Over Connector Issue
B BRAUN MEDICAL recalled its PERIFIX FX Continuous Epidural Anesthesia Set on September 18, 2025. The recall affects a potential defect in the catheter connector lid position. This high-risk issue could impact patient safety in healthcare settings across the country.
Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- B BRAUN MEDICAL
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
Hazard Information
Potential for the lid of the catheter connector to be in the incorrect position.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B BRAUN MEDICAL INC or your healthcare provider for instructions. Notification method: Letter
Product Details
The recalled product is the PERIFIX FX Continuous Epidural Anesthesia Set, including the PERIFIX Tuohy Epidural Needle (17 Ga. x 3-1/2 in.) and the PERIFIX FX Springwound Epidural Catheter (19 Ga. Closed tip). It has product codes CE17TFC and REF: 332238. The device was distributed nationwide.
The Hazard
The recall stems from a potential defect where the lid of the catheter connector may be incorrectly positioned. This issue poses a high risk of complications during epidural anesthesia procedures.
Reported Incidents
As of now, there are no reported injuries or incidents associated with this recall. The company is acting proactively to prevent any potential risks.
What to Do
Stop using the product immediately. Follow the recall instructions provided by B BRAUN MEDICAL. Contact them or your healthcare provider for further guidance.
Contact Information
For more information, visit the B BRAUN MEDICAL website or call their customer service for assistance.
Key Facts
- Recall date: September 18, 2025
- Class II medical device recall
- Potential for connector lid misalignment
- Nationwide distribution
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Safety Assessment
Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER
Product Classification
Product TypeEpidural Anesthesia Set
Tags
Sold At
Unknown
Product Details
Brand
Categories
Model Numbers
REF: 332238
Product Code: CE17TFC
UDI-DI (Primary): 04046964178603
UDI-DI (Unit of Use): 04046964178597
Lot Number: 0062014626
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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