The Recall Desk
HighFDA (Devices)·Z-2494-2021·Announced 2021-09-29

Ad-Tech Medical Cable Recalled Due to Incorrect Product Labels

Ad-Tech Lightweight CABRIO Cables with incorrect labels are being recalled. Mislabeling could cause product misidentification affecting proper use in clinical monitoring applications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall. The mislabeled cable represents a risk-of-harm product that could affect proper identification and clinical use. No illnesses or injuries have been reported, but the potential for harm from product misidentification in medical settings justifies High severity per the rubric.

Plain-English summary

Ad-Tech Medical Instrument Corporation is recalling Ad-Tech Lightweight CABRIO Cables due to incorrect labels applied to affected units. These cables are designed to connect electrodes to third-party monitors and stimulators in medical settings.

The recall affects 69 units distributed worldwide, including locations in the United States (DC, FL, MI, NY, PA, and TX) and internationally (Spain, France, Italy, Greece, Great Britain, and Canada). Multiple lot numbers across different cable models are included in this recall.

Incorrect labeling could lead to product misidentification, potentially affecting proper installation and use of the cables in clinical applications. Affected customers should stop using recalled units and contact Ad-Tech Medical Instrument Corporation for guidance on product identification or replacement.

The recalled product

Product
Ad-Tech Lightweight CABRIO Cable - Product Usage: Designed for the purpose of connecting these electrodes to third party monitors/stimulators.
Manufacturer
Ad-Tech Medical Instrument Corporation
Category
Medical Device — Cable / Connector
Hazard
  • mis-labeling
  • product-misidentification

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • Item Code & Lot #: L-SRL-10DIN Lot #'s 120340
  • 122140 and 124140
  • L-SRL-10DIN-84 Lot #'s 126270 and 127270
  • L-SRL-12BDIN Lot # 125250
  • L-SRL-16BDINLot #124150
  • L-SRL-20DINLot # 127060
  • L-SRL-32BDIN Lot # 126070 L-SRL-4DIN Lot #'s 123050
  • 129150 and 120250
  • L-SRL-64BDIN Lot #127270
  • L-SRL-6DINLot #'s 128060 and 120160
  • L-SRL-8DIN Lot #'s 128150 and 124050
  • L-SRL-8DIN-11 Lot # 125170

Distribution

Distributed nationwide across the United States.

Related recalls

Same category