Recall Z-1461-2023— Baxter Healthcare Corporation

Name: FDA recall Z-1461-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-27

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2023-03-27. It names one FDA 510(k) clearance: K983007. Product: GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for peripheral nerve repair. Reason: The product is brittle and potentially crumbling upon handling or when being removed from its package..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-03-27
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K983007 — NEUROTUBENeuroregen, LLC·cleared 1999-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.