GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for pe

FDA device recall Z-1461-2023 · posted 2023-04-25 · Open, Classified

Recall details

Recalling firm

Baxter Healthcare Corporation

Reason for recall

The product is brittle and potentially crumbling upon handling or when being removed from its package.

Action taken

Baxter issued an Urgent Medical Device Recall notice to its consignees on 03/27/2023 by mail (USPS). The notice explained the issue and the risk and requested the following actions: 1. Immediately locate, isolate, and cease all use of the affected lot number of the product. 2. Contact Synovis MCA to arrange for return and replacement of the product. Synovis MCA can be reached at 800-510-3318 or 205-941-0111 between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday. Please have your Synovis MCA account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you received this communication directly from Baxter, please acknowledge receipt by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any inventory. Log in to the portal using the account number listed on the enclosed reply form instruction sheet. 4. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JXI

Quantity affected

169 units

Distribution

Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France

Date initiated

2023-03-27

Date posted

2023-04-25

Location

Deerfield, IL

Related 510(k) clearances