Device recall
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
- Recall number
- Z-0067-2027
- Event id
- 99699
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Custom Interventional Pain Management, LLC
- Report date
- Oct 7, 2026
- Posted
- Oct 1, 2026
- Initiated
- Jan 15, 2026
- Center classification date
- Oct 1, 2026
- Product code
- OGE
- Device type
- Epidural Anesthesia Kit
- Reason
- Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
- Root cause
- Process control
- Quantity
- 56
- Code info
- Lot Code: CIPM product / reorder #17025; Description: 17g continuous PBN tray; Item #110026; Received Lot# 27022; Affected Lot #1225271; Expiration Date: 01/31/2028; DHR or Batch Record #64591; UDI: *+B87517LIDO/$$20131281225271T* UDI- DI #: B87517LID0 with Lidocaine
- Distribution
- U.S. Nationwide distribution in the state of TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- San Antonio, TX, United States