Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhe
Summary
The FDA issued a Class II for Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Managemen by Custom Interventional Pain Management, LLC. Reason: Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits..
Details
Source
Device Recall
External ID
Z-0067-2027
Action Date
2026-10-07
Status
Ongoing
Category
device
Product Description
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
Lot/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
Quantity Affected: 56
Reason for Recall
Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
Distribution
U.S. Nationwide distribution in the state of TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-15
Company
San Antonio, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 238 device recalls issued in the same week, part of 518 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Custom Interventional Pain Management, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Custom Interventional Pain Management, LLC have FDA actions?
This is the only FDA action we have on record for Custom Interventional Pain Management, LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0067-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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