Z-1430-2023Class II

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

Name: Z-1430-2023 Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full...
Creator: Aesculap Implant Systems LLC
Published: 2023-02-23
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2023-02-23 / Open, Classified / root cause: manufacturing process

FDA source

Aesculap Implant Systems LLC began a recall of 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... on 2023-02-23. FDA classified it as Class II and gives the reason as "Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1430-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-23
Posted: 2023-04-25
Recalling firm: Aesculap Inc
Product: 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
Product code: FSM Tray, Surgical, Instrument
Reason for recall: Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: ME754: 3 units; ME764: 22 units
Distribution: US Nationwide distribution in the states of CA, OH, NE, NH, FL, PA, TX.
Product codes and lots: GUIDID: 04046955299592 (Basket Lid)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1430-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1430-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-03	2023-04-25

Product code FSM

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)