Pacific Medical Fetal Transducers Recalled for Missing Regulatory Clearances
Pacific Medical Group Inc. is recalling 261 fetal transducers distributed in the U.S. and abroad before receiving required FDA and international clearances.
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. The source text indicates a regulatory compliance issue (distribution before clearance) without reporting specific injuries, illnesses, or deaths, which aligns with the criteria for a moderate severity score involving voluntary or precautionary regulatory actions.
Plain-English summary
Pacific Medical Group Inc. is recalling 261 units of the Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, model FFPH3250. The recall involves all serial numbers sold between October 24, 2014, 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 40 U.S. states and the District of Columbia, as well as in Canada, Colombia, France, Great Britain, Italy, Mexico, and the United Arab Emirates.
No specific injuries or illnesses have been reported in the source text. Users of these devices should contact Pacific Medical Group Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 261
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 10/24/2014 - 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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