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U.S. Department of Health and Human Services

Class 2 Device Recall MEGADYNE Suction Coagulators

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  Class 2 Device Recall MEGADYNE Suction Coagulators see related information
Date Initiated by Firm June 15, 2023
Date Posted July 28, 2023
Recall Status1 Open3, Classified
Recall Number Z-2257-2023
Recall Event ID 92456
510(K)Number K072559  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
Code Information Product Code 004125: UDI-DI: 10614559105146, Batch Numbers: 183661 184078 183932 183978 184625 184161 185463 184714 185887 186028 185625 185757 186207 186128 186325 190281 190276 190147 190420 190618 190696 190638 191023 190751 191115 191424 191816 192724 192882 193070 193135 193211 193355 193449 193541 193390 193403 194160 194100 193579 193819 193958 194669 194613 195265 195597 194473 194777 194814 194358 194912 195044 195046 196082 186379 195736 196130 196129 196726 196624 196583 196956 197226 200458 200509 200447 200910 200973 202143 201381 201224 201431 202185 202229 202607 202268 203198 202299 203196 202315 202603 202606 203558 207076 208392 207075 202605 207834 207833 209000 202949 208391 208922 204137 210624 210429 203956 203672 210070 209144 207077 209460 210237 204299 208845 207832 207602 206689 204298 206750 209459 211798 210071 207764 207601 207600 211800 207222 206815 208921 208018 211801 208054 210025 210287 210285 210288 210510 209205 211799 210430 208053 210236 210092 210094 210093 210026 211802 208055 210072 208348 210286 208390 209255 208179 208178 SM2204025 SM2204023 SM2204019 SM2204022 SM2204024 SM2204027 SM2204021 SM2204020 SM2204026 SM2206034 SM2206038 SM2206035 SM2206039 SM2206036 SM2206037 SM2210032; Product Code 004225: UDI-DI: 10614559105153, Batch Numbers: 183863 185939 186249 186007 185713 190855 191581 191218 190452 191770 191342 193933 194392 193588 194071 196131 194203 195789 196858 200030 197301 196905 197138 200625 201515 201636 201778 208923 201971 205151 209430 210162 210965 209311 209312 210160 204300 205152 205379 209229 205573 205676 208589 209431 209254 208588 209357 210164 209355 208696 209429 210163 208678 209356 209142 210161 SM2204032 SM2201024 SM2204030 SM2204028 SM2204033 SM2204034 SM2204029 SM2206028 SM2206033 SM2206032 SM2206030 SM2206029 SM2206031 SM2210033; Product Code 004325: UDI-DI: 10614559105160, Batch Numbers: 183957 183704 183846 184405 184694 184711 185401 184888 185626 186280 186162 186064 185858 186445 186650 186675 191072 191371 191191 191539 192761 192981 193071 193287 193286 193514 193175 194158 194475 195047 194612 193580 193846 194587 194864 194694 195536 186700 195670 195633 196132 196911 200523 200536 201087 201060 201335 201188 201299 201460 203064 201355 201970 202493 207796 208699 205381 205380 205154 207795 205153 209078 208698 209001 208880 210363 210364 209002 208791 208756 208879 209077 202608 202771 210362 210397 208755 208697 208700 203117 202772 203115 SM2204039 SM2206045 SM2206043 SM2206041 SM2206042 SM2206044 SM2204040 SM2206040 SM2204041 SM2209020 SM2210024; Product Code 0041BN: UDI-DI: 10614559103456, Batch Numbers: 181362 181463 184784 184885 185528 185560 185623 185747 191665 193242 193302 194239 194159 194024 195101 196385 195899 195102 200575 202465 202335 203472 208181 204814 208252 208846 208251 208847 204812 203420 SM2208013 SM2208011
Recalling Firm/
Manufacturer		 Megadyne Medical Products, Inc.
4545 Creek Rd
Blue Ash OH 45242-2803
Manufacturer Reason
for Recall		 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).
FDA Determined
Cause 2		 Under Investigation by firm
Action An "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" letter dated 6/15/23 was sent to customers. If you have additional questions regarding this recall or to report any customer complaints, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET. ACTION REQUIRED 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax or email to Sedgwick at 866-918-8739 or Ethicon8055@sedgwick.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to return unused MEGADYNE" Suction Coagulators subject to this recall that are in inventory immediately. To receive credit reimbursement, customers must return product subject to this recall no later than September 30, 2023 to Sedgwick at 866-918-8739 or Ethicon8055@sedgwick.com. Any non-affected product and any product returned after the date specified will not receive credit reimbursement. 5. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Megadyne will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be ob
Quantity in Commerce 241,457 units
Distribution Worldwide Distributions: US (Nationwide) and OUS (Foreign) in countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = MEGADYNE MEDICAL PRODUCTS, INC.
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