Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached remov

FDA device recall Z-2242-2023 · posted 2023-07-27 · Open, Classified

Recall details

Recalling firm

Davol, Inc.

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

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

FTL

Quantity affected

1599 units

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, Ind

Date initiated

2023-04-25

Date posted

2023-07-27

Location

Warwick, RI

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