The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2340-2017·Announced 2017-07-19

Oscor ATAR Reusable Extension Cables Recalled for Connector Separation Risk

Oscor, Inc. is recalling ATAR Reusable Extension Cables because they may separate from the connector during use, posing a risk to patients.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The Reusable Oscor ATAR extension cables could separate from the connector during use."

Plain-English summary

Oscor, Inc. is recalling ATAR Reusable Extension Cables, sold under brand names including ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. The recall involves 19,178 units distributed worldwide, including to the United States and various foreign countries.

The recall is being issued because the cables could separate from the connector during use. These cables are intended to connect an electrode or lead from a patient or another cable to a diagnostic machine or an external pacemaker.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect.

The recalled product

Product
ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2…
Manufacturer
Oscor, Inc.
Category
Medical Device — Cables and Connectors
Hazard
Affected units
19,178

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 (9)

  • 53912A - MDTS ATAR REUSABLE
  • ATAR-MDT2S-A DK BLUE 30CM REUSABLE (C1-08831 D2-04131)
  • ATAR-MDT2S-V WHITE 30CM REUSABLE (C1-08830 D2-04002)
  • ATAR-MDTL REUSABLE (D8-00005 D2-01352-00)
  • ATAR-MDTR REUSABLE (D2-02210 D2 02211 D2-02833 D2-02211)
  • ATAR-R REUSABLE (D2-03922 D2-01665)
  • ATAR-R T4P REUSABLE (D2-03560)
  • ATAR-V2 REUSABLE (D2-02787 D2-02647)
  • XI.R REUSABLE (D2-01665 D2-02141 D2-02423 D2-02449 D2-02486)

Distribution

Distributed in 39 states:

Part of a larger recall action

This product is one of 2 recalled by Oscor, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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