Pacific Medical recalls certain fetal transducers sold between Feb 2016 and Apr 2019 that were distributed without required U.S. regulatory clearance. This affects pregnant women using the device for monitoring.
Fetal transducers distributed in advance of receiving 510(k) and international clearances.
Pacific Medical is recalling specific fetal transducers that were distributed before receiving necessary U.S. regulatory approval. This could pose risks to pregnant women using the device for monitoring.
The transducers were distributed without proper U.S. regulatory clearance (510(k) and international clearances). This means they may not meet safety standards for fetal monitoring, potentially causing harm to the fetus or mother.
Pregnant women using the Pacific Medical Toco Transducer for fetal monitoring are most at risk. The recall applies to units sold between February 2016 and April 2019.
Check for the model number 2264HAX or FFCM3205 on the transducer. The device was sold between February 6, 2016, and April 30, 2019.
Look for the model number 2264HAX or FFCM3205 on the transducer.
The transducers were distributed without required U.S. regulatory clearance (510(k) and international clearances).
The model numbers 2264HAX and FFCM3205 are affected.
These transducers were sold between February 6, 2016, and April 30, 2019.
We’ve drafted a message you can send Pacific Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0979-2020 — Pacific Medical Pacific Medical Hello, I own a Pacific Medical that is covered by recall Z-0979-2020 from Pacific Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
