B. Braun Medical Recalls CE17TKFSA Full Tray Catheter Connectors
B. Braun Medical is recalling CE17TKFSA full trays because the catheter connectors may not stay closed, leading to leakage or disconnection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (leakage/disconnection) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the High severity criteria for risk-of-harm products without reported injury.
Plain-English summary
B. Braun Medical, Inc. is recalling 2,250 units of the CE17TKFSA Full Tray with 17G Tuohy and 19G Sprw (Material Number 332080). This connection device is used by physicians to provide a common access point to a catheter for the delivery of anesthetics and fluids.
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 affected batches are 61593847, 61603311, 61611233, and 61589431.
The product was distributed nationwide in the United States as well as in Australia, Canada, Guatemala, and Kuwait. Healthcare providers should stop using the affected devices and contact B. Braun Medical for further instructions.
The recalled product
- Product
- CE17TKFSA FULL TRAY W/17G TUOHY 19G SPRW, Material Number 332080 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
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 2,250
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: 61593847
- 61603311
- 61611233
- 61589431
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.
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