Oscor ATAR Disposable Extension Cables Recalled for Connector Separation Risk
Oscor, Inc. is recalling ATAR Disposable Extension Cables because they may separate from the connector during use, posing a risk to patients.
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: The recall is classified as FDA Class I, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. The hazard involves a medical device failing during use, which fits the criteria for High severity due to the risk of harm to patients, even though specific injury reports are not detailed in the provided text snippet.
Plain-English summary
Oscor, Inc. is recalling ATAR Disposable Extension Cables, sold under brand names including ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. The recall involves 36,242 units distributed worldwide, including across the United States and various foreign countries.
The recall was initiated because the cables could separate from the connector during use. This defect may compromise the connection between the patient's electrode/lead and the diagnostic machine or external pacemaker.
Healthcare facilities and consumers should stop using the affected cables immediately. Users should check their inventory against the specific model codes and lot numbers listed in the official FDA recall notice Z-2733-2017 to identify affected units.
The recalled product
- Product
- ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE, AT
- Manufacturer
- Oscor, Inc.
- Affected units
- 36,242
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 (8)
- ATAR D-MDTL DISPOSABLE (D2 02525)
- ATAR D-R NP DISPOSABLE (B4-10113 B4-10274 B4-10363 B4-13018 C1-06686)
- ATAR D-MDTR (D2-02210)
- ATAR D-R T4P (D2-03946)
- ATAR D-R X2 (C1-06767)
- XI.D-MDT DISPOSABLE 30 CM (D2-02367 D2-02367 D2-02450 D2-02480 D2-02861)
- XI.D-RL (D2-03578 D2-03715 OR-04766)
- XI.D-R DISPOSABLE (D2-02481)
Distribution
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.
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