FDA Recall Terminated

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.

Recall: Z-0791-2019 · Initiated January 14, 2019

Recall

Recall Number
Z-0791-2019
Event Number
81933
Firm
3M Company Health Care Business 3m Center
FEI Number
2110898
Product Code
LWK
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
January 14, 2019
Terminated
February 11, 2021
Address
2510 Conway Ave, B # 275-5-W-6, Saint Paul, MN, 55144-0001

Description

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.

Reason

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.

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.

Distribution

US Distribution and countries Brazil and Canada.

Quantity

19,860 units