Pacific Medical fetal transducers recalled for lack of regulatory clearance
Pacific Medical Group is recalling 772 fetal transducers distributed in the U.S. and abroad before receiving required FDA 510(k) and international clearances.
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 2/5 (Moderate).
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 source text does not report any illnesses, injuries, or deaths. The hazard is regulatory (lack of clearance) rather than a direct physical defect causing harm, fitting the Moderate category for low-risk or voluntary precautionary issues.
Plain-English summary
Pacific Medical Group Inc. is recalling 772 units of the GE Corometrics Nautilus Toco Transducer w/knob (model 2264HAX, FFCM3205). The recall affects all serial numbers sold between February 6, 2016, and April 30, 2019.
The recall was initiated because the fetal transducers were distributed in advance of receiving 510(k) and international clearances. The devices were distributed across 44 U.S. states and the District of Columbia, as well as in Canada, Colombia, France, Great Britain, Italy, Mexico, and the United Arab Emirates.
Healthcare providers and consumers should stop using the affected transducers and contact Pacific Medical Group Inc. for further instructions regarding the recall.
The recalled product
- Product
- Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 772
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 sold between 02/06/2016 - 04/30/2019
Distribution
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 →Related recalls
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