Reported Aug 9, 2023 · Ongoing
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product…
Megadyne Medical Products, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Megadyne Medical Products, Inc. · 4545 Creek Rd · Blue Ash, OH · 45242-2803
Is this the product you have?
MEGADYNE Suction CoagulatorsProduct Code 004125 (Suction CoagulatorHandswitching10 Fr6 inch (15.24cm))Product Code 004225 (Suction CoagulatorHandswitching8 Fr6 inch (15.24cm)Product Code 004325 (Suction CoagulatorHandswitching12 Fr6 inch (15.24cm))and Product Code 0041BN (Suction CoagulatorHandswitching10 Fr6 inch (15.24cm)Bulk Non Sterile)
- Lot codes and dates
- Product Code 004125UDI-DI: 10614559105146
- Batch Numbers
162 of 162 codes
183661184078183932183978184625184161185463184714185887186028185625185757186207186128186325190281190276190147190420190618190696190638191023190751191115191424191816192724192882193070193135193211193355193449193541193390193403194160194100193579193819193958194669194613195265195597194473194777194814194358194912195044195046196082186379195736196130196129196726196624
- Product Code 004225UDI-DI: 10614559105153
- Batch Numbers
70 of 70 codes
183863185939186249186007185713190855191581191218190452191770191342193933194392193588194071196131194203195789196858200030197301196905197138200625201515201636201778208923201971205151209430210162210965209311209312210160204300205152205379209229205573205676208589209431209254208588209357210164209355208696209429210163208678209356209142210161SM2204032SM2201024SM2204030SM2204028
- Product Code 004325UDI-DI: 10614559105160
- Batch Numbers
93 of 93 codes
183957183704183846184405184694184711185401184888185626186280186162186064185858186445186650186675191072191371191191191539192761192981193071193287193286193514193175194158194475195047194612193580193846194587194864194694195536186700195670195633196132196911200523200536201087201060201335201188201299201460203064201355201970202493207796208699205381205380205154207795
- Product Code 0041BNUDI-DI: 10614559103456
- Batch Numbers
181362181463184784184885185528185560185623185747191665193242193302194239194159194024195101196385195899195102200575202465202335203472208181204814208252208846208251208847204812203420SM2208013SM2208011
- Amount recalled
- 241,457 units
Where it was sold
- Nationwide
Why it was recalled
An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).
This product could cause temporary or reversible health problems — stop using it.
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