Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - L

FDA device recall Z-1430-2023 · posted 2023-04-25 · Open, Classified

Recall details

Recalling firm

Aesculap Implant Systems LLC

Reason for recall

Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.

Action taken

Aesculap Implant Systems, LLC, issued Urgent Medical Device Recall Notification letter on 2/23/23. Letter states reason for recall, health risk and action to take: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the end user/customer level. 2. Determine your current inventory of the affected lots within your facility. cease use and guarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached "Product Recall Acknowledgement Form," record the total number of individual units in your possession. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed "Product Recall Acknowledgment Form" 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 Acknowledgement Form, a B. Braun Customer Support representative will contact you to arrange for shipment of a replacement lid and to have your current inventory returned.

Root cause

Employee error

Status

Open, Classified

Product code

FSM

Quantity affected

ME754: 3 units; ME764: 22 units

Distribution

US Nationwide distribution in the states of CA, OH, NE, NH, FL, PA, TX.

Date initiated

2023-02-23

Date posted

2023-04-25

Location

Center Valley, PA