Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0791-2019Class II

3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove...

3M Company / initiated 2019-01-14 / Terminated / root cause: manufacturing process

3M Company - Health Care Business began a recall of 3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in... on . FDA classified it as Class II and gives the reason as "3M has recently received reports involving the 3MTM Surgical Clipper by Remington, Model 9602, overheating in mobile/field EMS situations while charging from a modified sine wave power inverter". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0791-2019
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
3M Company
Product
3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.
Product code
LWK Razor, Surgical
Reason for recall
3M has recently received reports involving the 3MTM Surgical Clipper by Remington, Model 9602, overheating in mobile/field EMS situations while charging from a modified sine wave power inverter.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
The firm, 3M Health Care, disseminated their "Field Safety Action" letter dated 1/9/2019 to its customers beginning on 01/14/2019. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: -Consult facility bio-med or power inverter manual/manufacturer to ensure only pure sine wave inverters are being used in mobile/field EMS situations to charge the 9602 clipper, as emphasized in the new product caution. -Complete and return the Customer Acknowledgement Form to show your understanding of and compliance with this Field Safety Action via Email to: [email protected]. If you have questions regarding this matter, please contact your local 3M sales rep or the 3M Health Care Customer Helpline at 1-800-228-3957, option #6, Monday through Friday, 7:30 a.m. 6:00 p.m. Central Time.
Quantity in commerce
19,860 units
Distribution
US Distribution and countries Brazil and Canada.
Product codes and lots
all lots

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0791-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0791-2019Class IITerminatedVoluntary: Firm initiated