San Clemente, CA, United States
Pacific Medical Group Inc. recalls
3 recalls recorded since 2018, most recently on 24 March 2021. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)3
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 24 March 2021
- Reason
- Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
- Distribution
- Distribution US nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1375-2021
- Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
Ongoing Class II Medical devices
- Recall started
- 19 September 2019
- Reason
- Fetal transducers distributed in advance of receiving 510(k) and international clearances.
- Distribution
- U.S.: IN, AZ, IL, HI, AK, AR, CA, FL, GA, IA, ID, LA, MA, NC, NE, NM, NY, OK, PA, TN, TX, UT, VA, WA, WV, NV, KY, CO, ME, ND, OH, SC, WI, AL, OR, DC, DE, MD, MI, MN, MO, MT, MS, NJ, NH. O.U.S. (Foreign): CA, CO, FR, GB, IT, MX, UAE
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0983-2020, Z-0981-2020, Z-0984-2020, Z-0985-2020, Z-0980-2020, Z-0979-2020, Z-0982-2020
- Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/wing 5700LAX, FFCM5260
- Pacific Medical GE Corometrics Nautilus Ultrasound Transducer w/knob, 5700HAX, FFCM5205
- Pacific Medical Philips M1355A Toco Transducer with belt wire/knob, FFPH3250
- Pacific Medical Philips M1356A Ultrasound Transducer with belt/wire knob, FFPH5250
- Pacific Medical GE Corometrics Nautilus Toco Transducer w/wing (2264LAX), FFCM3260
- Pacific Medical GE Corometrics Nautilus Toco Transducer w/knob, 2264HAX, FFCM3205
- Pacific Medical GE Corometrics Nautilus Ultrasound, 5700 (Old Style), FFCM5660
Ongoing Class II Medical devices
- Recall started
- 11 September 2019
- Reason
- Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.
- Distribution
- Worldwide Distribution - US Nationwide in the states of::NH, NY, MN, PA, FL, AZ, LA, GA, IL, HI, CA, OR, SC, OH, NC, IA, OK, AL, MA, MD, WI, MI, AR, WA, SD, NV, KY, TX, MS, DE, NJ, NE, WV, MT, TN, VA, MO, VT, CO, CT, ME, WY, IN, UT, NM, AK, DC, ID, KS, ND, RI, NH. OUS: BEL, ARE, MEX, CAN, CYM,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1164-2020, Z-1160-2020, Z-1168-2020, Z-1161-2020, Z-1165-2020, Z-1162-2020, Z-1163-2020, Z-1166-2020, Z-1159-2020, Z-1167-2020
- Ultrasound Transducer (M1356A), that may have been serviced with the following: Pacific Medical Philips M1356A Ultrasound Board, NFPH9510; Pacific Medical Philips M1356A Ultrasound Bottom Case, NFPH9515; Pacific Medical
- Loop-Style Tocotransducer (Nautilus) 2264LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Toco Board, NFCM9310; Pacific Medical GE Corometrics Nautilus TOCO Bottom Case, NFCM93
- Toco MP Transducer (M2734B), that may have been serviced with the following: Pacific Medical Philips M2734B Avalon Smart TOCO Bottom Case, NFPHA9315-B
- Button-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700HAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nauti
- Toco M2734A, that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A Toco Gauge Flex, NFPHA9341
- Loop-Style Ultrasound Transducer (Nautilus), 8-foot Cord 5700LAX, that may have been serviced with the following: Pacific Medical GE Corometrics Nautilus Ultrasound Board, NFCM9510; Pacific Medical GE Corometrics Nautilu
- External Toco Transducer (M1355A), that may have been serviced with the following: Pacific Medical Philips M1355A Toco Bottom Case, NFPH9315; Pacific Medical Philips M1355A Toco Cable Assembly, NFPH9320; Pacific Medical
- Toco+ transducer with ECG/IUP capability (wired), that may have been serviced with the following: Pacific Medical Philips Avalon Smart US/TOCO Cable Assembly, NFPHA9020; Pacific Medical Philips Avalon Smart M2734A/2735A
- and 2 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.