ECG leadwire sets recall
ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire…
Why was ECG leadwire sets recalled?
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
product does not have lot or serial codes REF/Catalog Number GTIN/UDI 2106389-001 00840682139960 2106389-002 00840682139779 2106389-003 none 2106389-004 none 2106389-005 00840682139786 2106389-006 none 2106390-001 00840682139687 2106390-002 00840682140232 2106390-003 none 2106390-004 none 2106391-001 00840682140799 2106391-002 00840682139830 2106391-003 none 2106391-004 none 2106391-005 00840682140348 2106391-006 none 2106393-001 00840682140287 2106393-002 none 2106393-003 00840682139885 2106393-004 none 2106397-001 00840682140522 2106397-002 00840682140461 2106397-003 00840682140041 2106398-001 none 2106398-002 none
- Product
- ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire…
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 58,045 units (31,108 US; 26937 OUS) in total
- Distribution
- Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malta, Mauritius, Mexico, Moldova, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Palestine (state of), Panama, Poland, Qatar, Republic of Serbia, Romania, Russia, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
- Recall date
- July 3, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)