Custom Interventional Pain Management, LLC recalls Brand Name: Ferndale Laboratories
Reason for recall
Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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 information
- Lot #
- Code: CIPM product / reorder #17025; Description: 17g continuous PBN tray
- Part / 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
What the firm is doing
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 Form QF-85-05-02 and return to denise@cipmtrays.com or quality@cipmtrays.com. For questions - call Toll Free 1-888-392-4514
DistributionShow detailsHide
U.S. Nationwide distribution in the state of TX.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0067-2027
- FDA device classification · OGEOfficial FDA classification for this device type
- CFR regulation · 21 CFR 868.5120The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Custom Interventional Pain Management, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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