The Recall Desk
SevereFDA (Devices)·Z-3381-2018·Announced 2018-10-10

B. Braun Medical Recalls Catheter Connectors Due to Leakage and Disconnection

B. Braun Medical is recalling 6,850 clamp-style catheter connectors because they may not stay closed, causing leakage or disconnection.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect (leakage/disconnection) that poses a significant risk of harm to patients during anesthetic administration.

Plain-English summary

B. Braun Medical, Inc. is recalling 6,850 units of the Clamp Style Cath. Connector 18-19 GA- LF, Material Number 332285. The recall involves specific batches: 61604193, 61588390, 61608054, and 61618113. These devices were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait.

The recall was initiated because the catheter connectors may not stay closed during use. In some cases, leakage or disconnection of the catheters from the connectors has been observed. The connectors are used by physicians to provide a common access point to a catheter for the continuous administration of anesthetic fluids.

This is an FDA Class II recall. Healthcare providers and facilities should stop using the affected devices and contact B. Braun Medical for instructions on return or replacement.

The recalled product

Product
CLAMP STYLE CATH. CONNECTOR 18-19 GA- LF, Material Number 332285 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunct
Affected units
6,850

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 (4)

  • Batch: 61604193
  • 61588390
  • 61608054
  • 61618113

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 93 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 93 products in this recall →