3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove...
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0791-2019 | Class II | Terminated | Voluntary: Firm initiated |
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