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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap

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  Class 2 Device Recall Aesculap see related information
Date Initiated by Firm April 16, 2021
Create Date September 27, 2021
Recall Status1 Terminated 3 on January 18, 2023
Recall Number Z-2578-2021
Recall Event ID 88327
510(K)Number K202124  
Product Classification Clip, implantable - Product Code FZP
Product PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
Catalog Number: FC700SU
Code Information All batch codes
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact SAME
800-258-1946
Manufacturer 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 Determined
Cause 2		 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: qa-recalls@aesculapusa.com 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 80 units
Distribution US Nationwide distribution in the states of FL, MI, NY, TX, WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FZP and Original Applicant = Aesculap Inc.
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