Reported Dec 14, 2016 · Terminated
3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF…
3M Company - Health Care Business
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: 3M Company - Health Care Business · 3m Center 2510 Conway Ave , B# 275-5-W-6 · Saint Paul, MN · 55144-0001
Is this the product you have?
- 3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40
- pads / case) Product Usage3M 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
- Lot codes and dates
- Product REF 9130 Lot Numbers2019-02DT (Expiration 02-2019) and 2019-03DU (Expiration 03-2019)
- Product REF 9735-LP Lot Numbers2019-02DB and 2019-02CY. (Both with Expiration 02-2019)
- Amount recalled
- 32,000 pads
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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