The Recall Desk
ModerateFDA (Devices)·Z-1503-2016·Announced 2016-04-27

Ad-Tech Recalls Sterile Electrode Cables Due to Package Failures

Ad-Tech is recalling 197 unopened sterile electrode connection cables because package failures compromised the sterile barriers.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves compromised sterile barriers identified during a simulation without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Ad-Tech Medical Instrument Corporation is recalling 197 units of unopened and unused sterile electrode connection system cables. These cables are intended to be used with compatible Ad-Tech electrodes to connect them to third-party monitors or stimulators. The affected models include various Lightweight TECH-ATTACH Cable models (L-DCL-4DINX, L-DCL-6DINX, L-DCL-8DINX, L-DCL-16BDINX, L-DCL-32BDINX, L-DCL-64BDINX), the FO TECH-ATTACH Connection Cable (FO-LDC-4DINX), and the Lightweight CABRIO Cable (L-SRL-64BDINX).

The recall was initiated because package failures, specifically compromised sterile barriers, were identified during a shipping simulation investigation. The affected products were distributed in the states of Georgia and Michigan, as well as in France, the United Kingdom, Colombia, and Brazil. Specific lot numbers are listed in the official recall notice.

Consumers and healthcare facilities should stop using these specific cables and contact Ad-Tech Medical Instrument Corporation for instructions on how to return the product or obtain a replacement. The recall number for this action is Z-1503-2016.

The recalled product

Product
Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: 1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connectors each); 2. L-DCL-6DINX (6 contacts: 1 terminal block with 6 connectors each); 3. L-DCL-8DINX (8 contacts: 1 terminal bl
Affected units
197

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 (15)

  • Lot Numbers: 208140507
  • 208140552
  • 208140556
  • 208140559
  • 208140560
  • 208140561
  • 208140562
  • 208140563
  • 208140564R
  • 208140579
  • 208140581
  • 208140586
  • 208140588R
  • 208140590
  • 208140604.

Distribution

Distributed in 2 states: