Flextip Plus Closed Tip Epidural Catherter

• • Ongoing Z-2364-2026 FDA Class I ·initiated 21 Apr 2026

  Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

• • Terminated Z-1179-2020 FDA Class II ·initiated 15 Jan 2020

  There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.

• • Terminated Z-1962-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-2462-2015 FDA Class II ·initiated 30 Jul 2015 ·on shared 510(k) K103658

  the catheter peel-away component hub tabs may prematurely detach. One injury reported.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K103658 ↗

FDA Product Code

CAZ

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the FlexTip Plus Closed Tip Epidural Catheter and how does its design reduce risks during insertion?

  The FlexTip Plus Closed Tip Epidural Catheter is designed for epidural anesthesia and analgesia procedures, delivering medication directly into the epidural space. Its closed tip and wire-reinforced polyurethane construction help minimize risks like vessel puncture and paresthesia by reducing the likelihood of accidental needle-like trauma during insertion. The reinforced design also prevents kinking, ensuring consistent patency for reliable drug administration.

• Is the FlexTip Plus Closed Tip Epidural Catheter reusable or intended for single-use only, and how is it supplied?

  The FlexTip Plus Closed Tip Epidural Catheter is explicitly designed for single-use only. It is supplied sterile, ready for immediate clinical use in settings requiring epidural administration, ensuring patient safety and compliance with infection control protocols.

• What gauge size is available for the FlexTip Plus Closed Tip Epidural Catheter, and how does this affect its use?

  The catheter is available in a 19-gauge size, which balances flexibility with durability for epidural procedures. The 19-gauge size is commonly used for epidural anesthesia and analgesia, providing a balance between ease of insertion and adequate drug flow while minimizing tissue trauma.

• How should the FlexTip Plus Closed Tip Epidural Catheter be stored, and are there any special handling requirements?

  Since the catheter is supplied sterile, it should be stored in its original packaging in a clean, dry environment, protected from contamination and extreme temperatures. Avoid exposure to direct sunlight or moisture, as this could compromise sterility or material integrity. Always follow manufacturer guidelines for storage to maintain device performance and patient safety.

• What regulatory pathway was followed for the FlexTip Plus Closed Tip Epidural Catheter, and which advisory committee was involved?

  The FlexTip Plus Closed Tip Epidural Catheter underwent a Traditional 510(k) review through the FDA’s Anesthesiology (AN) Advisory Committee. It was determined to be substantially equivalent to a predicate device under FDA regulation 868.5140, ensuring compliance with safety and effectiveness standards for epidural catheters.