Recall Z-0791-2019 ยท LWK Razor, Surgical
3M Company - Health Care Business
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.
| Date | Jan 14, 2019 |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 19,860 units |
| Distribution | US Distribution and countries Brazil and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.