Flamingo Funnel Medium Class II Recall Non-Gamma Compatible Drape

Class 2 Device Recall Flamingo Funnel Medium (also referred to as microSQUAIR)

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| | Class 2 Device Recall Flamingo Funnel Medium (also referred to as microSQUAIR) | |

2300 Myrtle Ave Ste 200
Saint Paul MN 55114-1948 |
| For Additional Information Contact | Morgan Evans
281-3820523 |
| Manufacturer Reason
for Recall | Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. |
| FDA Determined
Cause | Packaging change control |
| Action | An URGENT: MEDICAL DEVICE RECALL notification letter was sent to customers beginning 3/16/26.

Actions to be taken by the Customer/End User:
1. Immediately discontinue use of this product. Note: The lots listed in this notice are the only lots impacted. All subsequently built product contains a correct, gamma compatible drape.
2. Dispose of impacted product according to local and national waste disposal procedures. Note: ALL PRODUCT MUST BE ACCOUNTED FOR ON THE MEDICAL DEVICE RECALL RETURN RESPONSE ACKNOWLEDGEMENT AND RECEIPT FORM.
3. Acknowledge receipt of this notice. Complete and return the attached Medical Device Recall Return Response Acknowledgement and Receipt Form via phone, US Mail, or email even if you no longer have any affected product in inventory:
Phone: Communicate the information required in the attached form by calling the toll free number: 1-800-557-3698 - available M-F between 8:00AM and 6:00PM CST
US Mail: Complete the attached form, and mail it back using the enclosed self-addressed, stamped envelope (if notice received by mail)
Email: Complete the attached form and return it to quality@surgismokesolutions.com
Please forward this notification to any additional customers to whom the affected product may have been distributed.

Type of Action by the Company:
In addition to this Recall activity, Nascent Surgical has initiated Corrective Action and Preventive Action measures that include but are not limited to:
Correcting the Bill of Materials to include a gamma compatible drape (completed Jan 2025)
Changing the packaging configuration to remove the fold (completed Jan 2025)
Improving Quality System Planning and other procedures to prevent recurrence

Other Information:
If you have additional questions about this notice, please contact us:
By phone 1-800-557-3698 (toll free) - available M-F between 8:00AM and 6:00PM CST
By emailing quality@surgismokesolutions.com |
| Quantity in Commerce | 2505 units total |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada. |
| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |

| 510(K) Database | 510(K)s with Product Code = FYD |