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U.S. Department of Health and Human Services

Class 2 Device Recall Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM

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 Class 2 Device Recall Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPMsee related information
Date Initiated by FirmJanuary 15, 2026
Date PostedOctober 01, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0067-2027
Recall Event ID 99699
Product Classification Epidural anesthesia kit - Product Code OGE
ProductBrand 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
Code Information 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
FEI Number 3008552585
Recalling Firm/
Manufacturer		 Custom Interventional Pain Management, LLC
12460 Network Blvd Ste 106
San Antonio TX 78249-3366
For Additional Information ContactDenise Ontiveros
001-210-2361764
Manufacturer Reason
for Recall		Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.
FDA Determined
Cause 2		Process control
ActionOn 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
Quantity in Commerce56
DistributionU.S. Nationwide distribution in the state of TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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