FDA-Device2026-10-07Class IIPROCESSING DEFECT
Mastisol Skin Adhesive recalled for manufacturing defects in surgical trays
What this means
Mastisol Skin Adhesive, a sterile surgical glue used in regional anesthesia procedures, is being recalled due to manufacturing issues with the product contained in surgical convenience trays. The recall affects a specific lot used in continuous epidural trays distributed nationwide.
- If you are a healthcare facility or anesthesia provider, check your inventory for affected lot #1225271 (Mastisol 17g continuous PBN tray, Item #110026) with expiration date 01/31/2028.
- Do not use affected trays. Contact your supplier or manufacturer for instructions on return or replacement.
The agency's original wording
Hazard
Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution in the state of TX.
Affected count
56
Manufactured in
12460 Network Blvd Ste 106, San Antonio, TX, United States
Products
Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog Number: 24161B (Ferndale and Medline); Tray 17025 17g continuous PBN tray (CIPM) Software Version: n/a Product Description: Skin Adhesive in a narrow plastic sterilized tube. Mastisol is a skin glue often used during surgical procedures. Continuous epidural trays are designed for use by anesthesiologists and radiologists in the administration of regional anesthesia. Component: surgical kits
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0067-2027Want us to check the next one for you?
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