Recall Z-0067-2027 ยท OGE Epidural Anesthesia Kit
Custom Interventional Pain Management, LLC
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 tray
| Date | Oct 1, 2026 (initiated Jan 15, 2026) |
| Status | Open, Classified |
| Reason | Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits. |
| Root cause | Process control |
| Action | On 01/15/2026, a customer notification letter was email to a single customer informing them that, the MASTISOL Liquid adhesive shipped in kits in lot 1225271, P.O.#2513972 was exposed to a double sterilization cycle by Ferndale Laboratories, Inc. which may contribute to the butyrate tubing being brittle and cracking during actuation. The customer was instructed to: 1. lmmediately examine your inventory and quarantine Lot 1225271. 2. Return all units of MASTISOL in Lot 1225271 to: CIPM 12460 Network Blvd. Suite 106 San Antonio, TX 78249 3. Complete the enclosed Return Materials Authorization F |
| Quantity | 56 |
| Distribution | U.S. Nationwide distribution in the state of TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.