Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Lock LOR Tray (Kit) A collection of devices int

FDA device recall Z-1150-2024 · posted 2024-02-16 · Open, Classified

Recall details

Recalling firm

B. Braun Medical, Inc.

Reason for recall

Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.

Action taken

B.Braun issued Urgent Medical Device Recall letter on Monday, January 22, 2024. Letter states reason for recall, health risk and action to take: 1. Review the Device Recall Notification and ensure that all users of the product in your organization, and other concerned personnel are informed about this recall. If you are a distributor and have further distributed the product, please forward this notice to your consignees. The recall is to be extended to the user level. 2. Determine your current inventory of the affected batches within inventory of your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Record the total number of individual impacted units on the Recall Acknowledgement Form. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Recall Acknowledgement Form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we receive your Recall Acknowledgement Form, a B. Braun Customer Support representative will contact you with instructions on how to return any impacted cases, including partial cases, in your possession and provide credit and/or replacement of the product based on your individual needs.

Root cause

Process control

Status

Open, Classified

Product code

OGE

Quantity affected

3,890 units

Distribution

US Nationwide

Date initiated

2024-01-22

Date posted

2024-02-16

Location

Allentown, PA