3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP
FDA device recall Z-0701-2017 · posted 2016-12-03 · Terminated
Recall details
- Recalling firm
- 3M Company - Health Care Business
- Reason for recall
- 3M is recalling Universal Electrosurgical Pads because a report of an unintended material (process liner) in the product. This may prevent or impede the safe return of electrosurgical current following Electrosurgical Unit (ESU) activation. This defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body.
- Action taken
- 3M sent an Urgent Medical Device Recall letter dated October 26, 2016 to affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to complete and return the attached Customer Product Return and Recall Form. Customers with questions can contact 3M Health Care Customer Helpline at 1-800-228-3957, 8:30 am - 7:00 pm EST.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 32,000 pads
- Distribution
- Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, FL, GA, ID, IL, KY, NC, NY, TN, TX, VA and the countries of Canada, Chile, Costa Rica, Germany, Japan, Mexico and South Africa.
- Date initiated
- 2016-10-26
- Date posted
- 2016-12-03
- Date terminated
- 2017-08-01
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3M UNIVERSAL ELECTROSURGICAL PAD, WITH CORD (CATALOG NUMBER 9135), 3M UNIVERSAL ELECTROSURGICAL PAD, SPLIT WITH CORD (C) (K974279) | 3M Healthcare | 1998-01-30 |