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Open, Classified

Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - Lid Only. A lid to a container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments. Note: The CCR basket lid is also distributed with ME764 CCR Basket - Full System

FDA Recall Z-1430-2023 · Posted 2023-04-25

Recall StatusOpen, Classified
Product CodeFSM
Date Initiated2023-02-23
Product QuantityME754: 3 units; ME764: 22 units

Reason for Recall

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

Firm Action

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 [email protected] 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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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