Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2756-2019Class II

Medline Electric Surgical Clipper and Base, Ref Dynd70800

MEDLINE INDUSTRIES, LP - Northfield / initiated 2019-09-06 / Open, Classified / root cause: manufacturing process

Medline Industries Inc began a recall of MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clipper is intended for the removal of body hair from the patient as... on . FDA classified it as Class II and gives the reason as "The recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2756-2019
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clipper is intended for the removal of body hair from the patient as required prior to surgery or other minor procedures.
Product code
LWK Razor, Surgical
Reason for recall
The recall is being conducted due to a potential defective component on the circuit board causing the charger base to overheat which could result in a charger base malfunction.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Medline Industries initiated the recall on 09/06/2019 by letter. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Immediately check your stock for the affected item number and lot number listed on the destruction form. Quarantine all affected product. Destroy all product belonging to the affected lot numbers listed on the destruction form. 2. Please return the completed enclosed destruction form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form. For questions contact 866-359-1704.
Quantity in commerce
500 units
Distribution
US Nationwide Distribution
Product codes and lots
14G1

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2756-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2756-2019Class IIOngoingVoluntary: Firm initiated