Z-0701-2017 Class II Terminated
FDA device recall Z-0701-2017 was initiated by 3M Company - Health Care Business on Oct 26, 2016 and is designated Class II. 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… The recall status is terminated (terminated Aug 1, 2017). Affected quantity: 32,000 pads.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 14, 2016
- Initiation Date
- Oct 26, 2016
- Termination Date
- Aug 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,000 pads
Product Description
3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Style Universal Electrosurgical Pad is for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY, etc.). 3M Universal Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this product. Use of this product for unintended application could lead to an unsafe condition.
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.
Distribution Pattern
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.
Code Information
Product REF 9130 Lot Numbers: 2019-02DT (Expiration 02-2019) and 2019-03DU (Expiration 03-2019) Product REF 9735-LP Lot Numbers: 2019-02DB and 2019-02CY. (Both with Expiration 02-2019)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0701-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026