Z-3328-2018Class II

CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 Connection device used by physicians to...

Name: Z-3328-2018 CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 Connection device used by physicians to...
Creator: B. Braun Medical, Inc.
Published: 2018-07-20
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2018-07-20 / Terminated

FDA source

B. Braun Medical, Inc. began a recall of CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 Connection device used by physicians to provide various anesthetic and fluid administration... on 2018-07-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3328-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-20
Posted: 2018-10-01
Terminated: 2020-05-13
Recalling firm: B Braun Medical Inc
Product: CONTIPLEX ECHO OT W/4" TUOHY ULTRA SET, Material Number 331762 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.
Product code: BSO Catheter, Conduction, Anesthetic
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.
FDA root cause: Under Investigation by firm
Action: The firm, B. Braun, sent an "URGENT MEDICAL DEVICE CORRECTION RECALL NOTIFICATION" letters dated 7/20/18 to its customers. The letters described the product, problem and actions to be taken. The letters instruct customers to do the following: 1. Review this Medical Device Correction Notification in its entirety and ensure that all users of the mentioned products in your organization and other concerned persons are informed about this Medical Device Correction Recall Notification. If you are a distributor, please forward this recall notification to your customers. 2. For continued safe use of the Perifix Catheter Connector as part, review and follow the instructions described in Attachment 2, Step-by-Step Correction of the Perifix Catheter Connector using Label. 3. For continued safe use of the Perifix Catheter Connector, review and follow the instructions described in Attachment 3, Step-by-Step Correction of the Perifix Catheter Connector using Cloth/Silk Medical Tape. This method can be applied to the Perifix Catheter Connector in Procedural Trays. 4. Utilizing the attached Medical Device Correction Recall Notification Acknowledgement form, please acknowledge that you have received and reviewed this information. 5. Return the completed Medical Device Correction Recall Notification Acknowledgement form to B. Braun Medical Inc. Quality Assurance department by faxing to: 610-849-1197 or e-mailing to: [email protected] the form within two (2) weeks of receipt of this notice. It is important this form is returned so B. Braun Medical Inc. can meet regulatory requirements of the United States Food and Drug Administration. 6. If you have any affected products as identified in attachment 1 that you choose to return instead of following the continued safe use instructions within Attachment 2 and 3, please identify on the Medical Device Correction Recall Notification Acknowledgement form that you will be returning t
Quantity in commerce: 190
Distribution: Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.
Product codes and lots: Batch: 61598015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3328-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3313-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3314-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3315-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3316-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3317-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3318-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3319-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3320-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3321-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3322-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3323-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3324-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3325-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3326-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3327-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3328-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3329-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3330-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3331-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3332-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3333-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3334-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3335-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3336-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3337-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3338-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3339-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3340-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3341-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3342-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3343-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3344-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3345-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3346-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3347-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3348-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3349-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3350-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3351-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3352-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3353-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3354-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3355-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3356-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3357-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3358-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3359-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3360-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3361-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3362-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3363-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3364-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3365-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3366-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3367-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3368-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3369-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3370-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3371-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3372-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3373-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3374-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3375-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3376-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3377-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3378-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3379-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3380-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3381-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3382-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3383-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3384-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3385-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3386-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3387-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3388-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3389-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3390-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3391-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3392-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3393-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3394-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3395-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3396-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3397-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3398-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3399-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3400-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3401-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3402-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3403-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3404-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01
Z-3405-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-10	2018-10-01

Product code BSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)