—#199278

Product

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

FDA product code: JXI — Cuff, Nerve
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K983007
Affected lot / code info: a) 5311-01240-010, Lot Number 19012112, exp. 12/31/2023; b) 5311-01240-012, Lot Number 19012112, exp. 12/31/2023

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

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

Timeline

Recall initiated: 2023-03-27
Posted by FDA: 2023-04-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199278. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.