CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report
Ce17tf Perifix Fx Contin recalled by B. Braun Medical
B. Braun Medical is recalling Ce17tf Perifix Fx Contin, distributed nationwide in the US. The recall was initiated on 20 Jul 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3371-2018
- FDA event ID
- 80811
- Recalling firm
- B. Braun Medical, Allentown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jul 2018
- FDA classified
- 1 Oct 2018
- Reported
- 10 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 20 Jul 2018 | Recall initiated by company | |
| 1 Oct 2018 | Classified by FDA | +73 days |
| 10 Oct 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
CE17TF PERIFIX FX CONTIN. EPIDURAL SET, Material Number 332234 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 conjunction with the catheter for continuous administration of anesthetic fluids.
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.
Questions about this recall
Is Ce17tf Perifix Fx Contin recalled?
Yes. B. Braun Medical recalled Ce17tf Perifix Fx Contin on 20 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-3371-2018.
Why was it recalled?
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Which lots are affected?
Batch: 61589584, 61617132, 61622878
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |