Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
- Company
- Davol, Inc.
- Recall Initiated
- April 25, 2023
- Posted
- July 27, 2023
- Recall Number
- Z-2241-2023
- Quantity
- 1188 units US; 5 units OUS
- Firm Location
- Warwick, RI
Reason for Recall
Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection
Distribution
Worldwide distribution - US Nationwide and the countries of Belgium, Czech Republic, France, Germany, Ireland, Italy, Netherlands, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK, India, Hong Kong, Greece, Chile, and Colombia.
Lot / Code Info
UDI-DI: (01)00801741031724(17)240428(10) Lot Numbers: HUGS0481 HUGS0549 HUGS1019 HUGS2031 HUGS2079 HUGT1627 HUGS2025 HUGT1989
Root Cause
Under Investigation by firm
Action Taken
BD issued Urgent Medical Device Product Recall letter on 4/25/23 via FedEx 2-day and email. Letter states reason for recall, health risk and action to take: 1. Please immediately discontinue use of the affected product. Check all inventory locations within your facility and destroy all affected product in accordance with your facility s process. 2. Share this notification with all users of the affected product within your facility network to ensure they are also aware of this product recall. 3. If you purchased the affected product from a distributor, contact your distributor directly for further instructions and credit resolution. 4. Complete the attached Customer Response Form and return it to the BD contact noted on the form whether or not you have any of the affected product so that BD may acknowledge your receipt of this notification per FDA requirements. 5. Indicate on the response form the quantity of affected product identified at your facility and confirm that this product inventory was destroyed. 6. Please contact your BD representative if you require assistance with this process, or you may also contact BD. 1. BD will issue replacements for destroyed product to customers that purchased product directly from BD following receipt of the completed Customer Response Form. 2. BD is implementing actions to prevent recurrence of this product issue. Contact Information: If you require further assistance please contact: BD Contact Contact Information Areas of Support North American Regional Complaint Center Phone: 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT Email: productcomplaints@bd.com Recall questions, Product Complaints, Technical Questions