Z-2579-2021Class II

PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13

Name: Z-2579-2021 PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
Creator: Aesculap Implant Systems LLC
Published: 2021-04-16
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2021-04-16 / Terminated

FDA source

Aesculap Implant Systems LLC began a recall of PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13 on 2021-04-16. FDA classified it as Class II and gives the reason as "Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2579-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-16
Posted: 2021-09-27
Terminated: 2023-01-18
Recalling firm: Aesculap Inc
Product: PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13
Product code: FZP Clip, Implantable
Reason for recall: Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
FDA root cause: Under Investigation by firm
Action: Aesculap issued An Urgent Medical Device Recall notification via USPS overnight to consignees on April 16, 2021. Letter states reason for recall, health risk and action to take: Immediately examine your inventory, identify and quarantine product related to this notification recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this Recall Notification. Your notification to your customers may be enhanced by including a copy of this notification letter. 1. Review the PAS-PORT Proximal Anastomosis System Recall Notification in its entirety and ensure that all users in your organization and other concerned persons are informed about this notification. 2. If you have further distributed this product, please identify and notify your customers of this action. We are requesting the product be returned. 3. Action is required of you to sign and return the provided Acknowledgement Response Form identifying (if applicable) the amount of product you have in your inventory. If you don t have any affected product, please enter zero in the space provided on the acknowledgement form. Please email to the address listed below before May 16, 2021. If the acknowledgement form has not been received at this time, another Recall Notification Letter will be sent. (Attachment 1 Medical Device Recall Notification Form). Send To: [email protected] 4. Identify your current inventory for the affected product. a. If you have identified inventory in your facility, DO NOT DESTROY any affected product. Contact Customer Service (info noted below) for an RGR number and return label to return your affected product. AIC Customer Service 1-800-282-9000 b. Once the RGR and return paperwork is provided, return a copy along with your affected product to the address listed below. Aesculap Inc. 615 Lambert Pointe Drive Hazelwood, MO 63042
Quantity in commerce: 350 units
Distribution: US Nationwide distribution in the states of FL, MI, NY, TX, WI.
Product codes and lots: All batch codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2579-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2578-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-27
Z-2579-2021	Class II	Terminated	Voluntary: Firm initiated	2021-10-06	2021-09-27

Product code FZP

K202124Class IIAesculap PAS-Port Proximal Anastomosis SystemAesculap, Inc. / cleared 2020-09-02

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)