Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101

FDA device recall Z-2221-2024 · posted 2024-06-27 · Completed

Recall details

Recalling firm

ASPEN SURGICAL

Reason for recall

The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.

Action taken

An URGENT: FIELD SAFETY NOTICE (Removal) dated 6/3/24 was sent to customers. Required Actions: Note: Any further distribution or use of the impacted product should cease immediately. 1. Check all storage and usage locations to confirm if you have any lots of the affected item code in your possession. 2. Distributors Please check your inventory for affected products as indicated above. For products that you have distributed, please forward this notification to your customers who have received affected product. Please also provide to Aspen a list of customers who have received these products, including the number of each product and contact information for each customer, to christi.fortenberry@aspensurgical.com. 3. Review, complete, sign and return the enclosed Acknowledgement Form on Page 3 by following the directions on the form. This will help us verify that you have been successfully supported by this corrective action. 4. Return any affected product found in your inventory. Your sales representative can assist with a Return Material Authorization of affected product if needed. 5. Contact Christi Fortenberry at christi.fortenberry@aspensurgical.com or 615.785.5933 for information on credit or replacement options. 6. Share this notice with others in your facility who need to be aware of this removal. Contact other facilities associated with your organization that may have received units of affected lots. 7. Maintain awareness of this notice until all affected product has been returned to Aspen Surgical. 8. Keep a copy of this notice with affected product until returned to Aspen. Please complete this Acknowledgement of Receipt form and email to christi.fortenberry@aspensurgical.com within 24 hours of receipt. Please contact your Aspen representative if you have any questions or require additional information.

Root cause

Process control

Status

Completed

Product code

GCJ

Quantity affected

1900 units

Distribution

US Nationwide

Date initiated

2024-06-03

Date posted

2024-06-27

Location

Caledonia, MI

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