Pacific Medical Group Recalls Button-Style Tocotransducers Due to Unverified Components
Pacific Medical Group is recalling 9,679 Button-Style Tocotransducers serviced with non-OEM components that were not appropriately verified, posing risks of inaccurate monitoring and burns.
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 recall is classified as FDA Class II and involves potential for patient/clinician burns and failure to detect fetal/maternal distress, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Pacific Medical Group Inc. is recalling 9,679 units of the Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX. The recall affects devices that may have been serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. The affected units were serviced between April 13, 2015, and April 2, 2019, and were distributed nationwide in the United States and in various countries worldwide.
The recall is due to the use of unverified components, which may result in the inability to accurately detect and measure fetal heart rate, maternal peripheral oxygen saturation, uterine activity, temperature, or maternal blood pressure. Additionally, the devices may lack electrocardiography tracing, cause patient or clinician burns, or lead to a delay in detecting maternal or fetal distress.
Healthcare facilities and consumers should stop using the affected devices immediately. Pacific Medical Group is the recalling firm responsible for addressing the issue. Users should contact the manufacturer for further instructions on how to proceed with the recall.
The recalled product
- Product
- Button-Style Tocotransducer (Nautilus), 8-foot Cord 2264HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM9315; Pacific Medical GE Corometrics Nautilus…
- Manufacturer
- Pacific Medical Group Inc.
- Affected units
- 9,679
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 serviced between 4/13/15 and 4/2/19.
Distribution
Part of a larger recall action
This product is one of 10 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.
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