The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0980-2020·Announced 2020-02-12

Pacific Medical Fetal Transducers Recalled for Lack of Regulatory Clearance

Pacific Medical Group Inc. is recalling 628 fetal transducers distributed without 510(k) clearance. The devices may fail to monitor vital signs, posing risks of burns or delayed detection of distress.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 source explicitly lists 'patient/clinician burns' as a possible adverse clinical impact. Per the rubric, FDA Class II recalls with reports of significant injury (burns) are classified as Severe (Score 4).

Plain-English summary

Pacific Medical Group Inc. is recalling 628 units of the GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260. These fetal transducers were distributed in the United States and several foreign countries between February 6, 2016, and April 30, 2019, prior to receiving the required 510(k) and international clearances.

The recall is due to the lack of regulatory clearance, which raises concerns about the device's ability to accurately detect and measure fetal heart rate, maternal peripheral oxygen saturation, uterine activity, temperature, and maternal blood pressure. The source text notes that device failure could lead to a lack of electrocardiography tracing, patient or clinician burns, and interruption of monitoring. These issues could result in a delay in detecting maternal or fetal distress.

The affected units were distributed across 43 U.S. states and the District of Columbia, as well as in Canada, Colombia, France, Great Britain, Italy, Mexico, and the UAE. Healthcare facilities and consumers should stop using these devices and contact the recalling firm for further instructions.

The recalled product

Product
Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
Manufacturer
Pacific Medical Group Inc.
Category
Medical Device — Fetal Monitoring
Hazard
Affected units
628

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 (1)

  • All serial numbers distributed between 02/06/16 - 04/30/19.

Distribution

Distributed in 45 states:

Part of a larger recall action

This product is one of 7 recalled by Pacific Medical Group 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 7 products in this recall →

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