—#166551

Product

CONTIPLEX TUOHY SET, 18GX4", 1.3X100MM, Material Number 331693 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.

FDA product code: BSO — Catheter, Conduction, Anesthetic
Device class: Class 2
Medical specialty: Anesthesiology
Affected lot / code info: Batch: 61611404, 61622440

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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: PA_QualityAssurance.BBMUS_Service@bbraunusa.com 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

Recalling firm

Firm: B. Braun Medical, Inc.
Address: 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

Timeline

Recall initiated: 2018-07-20
Terminated: 2020-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #166551. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.