Z-1461-2023 Class II Ongoing
FDA device recall Z-1461-2023 was initiated by Baxter Healthcare Corporation on March 27, 2023 and is designated Class II. Reason for recall: The product is brittle and potentially crumbling upon handling or when being removed from its package. The recall status is ongoing. Affected quantity: 169 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 3, 2023
- Initiation Date
- March 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 169 units
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of China, Germany, Sweden, Norway, Netherlands, Greece, Switzerland, France
Code Information
a) 5311-01240-010, Lot Number 19012112, exp. 12/31/2023; b) 5311-01240-012, Lot Number 19012112, exp. 12/31/2023