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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2026-04-21Z-2382-2026Class IOpen, ClassifiedLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.Distribution: US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.444,943code info di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-01-15NAINo action indicatedTeleflex Medical OEM LLC0
2024-03-18NAINo action indicatedTeleflex LLC (NADC)0
2024-03-18NAINo action indicatedTeleflex LLC (NADC)0
2024-01-26NAINo action indicatedTeleflex Medical OEM LLC0
2022-12-09NAINo action indicatedTeleflex Medical de Tecate, S. de R.L de C.V. (A Teleflex Medical Company)0
2022-08-26VAIVoluntary action indicatedTELEFLEX LLC3
2022-08-26VAIVoluntary action indicatedTELEFLEX LLC3
2021-09-02NAINo action indicatedTELEFLEX LLC0
2021-09-02NAINo action indicatedTELEFLEX LLC0
2021-07-30VAIVoluntary action indicatedTeleflex LLC (NADC)4
2017-09-21NAINo action indicatedTeleflex LLC0
2017-09-20VAIVoluntary action indicatedTeleflex Medical, Inc.1
2017-02-02NAINo action indicatedTeleflex Medical OEM LLC0
2016-08-29NAINo action indicatedTeleflex Medical OEM LLC0
2016-03-03NAINo action indicatedTeleflex LLC (NADC)0
2016-03-03NAINo action indicatedTeleflex LLC (NADC)0
2015-08-13NAINo action indicatedTeleflex Medical Sdn. Bhd.0
2015-06-05NAINo action indicatedTeleflex Medical Europe Ltd0
2015-02-25NAINo action indicatedTeleflex Medical Europe, Ltd.0
2014-08-28NAINo action indicatedTELEFLEX LLC0
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