Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0207-2007

OneTouch/Basic/Profile Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a...

Medishop USA / initiated 2006-10-17 / Terminated / root cause: manufacturing process

Medishop USA began a recall of OneTouch/Basic/Profile Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled... on . The reason FDA records is "Counterfeit-(manufacturer unknown)". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0207-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medishop USA
Product
OneTouch/Basic/Profile Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled in English, Greek and Portuguese)
Product code
NBW System, Test, Blood Glucose, Over The Counter
Reason for recall
Counterfeit-(manufacturer unknown)
Root cause tag
manufacturing process
FDA root cause
Other
Action
The recalling firm faxed, e-mailed and/or mailed ''Urgent Medical Device'' letters and response forms (dated 10/17/06) to the 5 distributor accounts.
Quantity in commerce
7,727 boxes (50 strips per box)
Distribution
Worldwide Distribution-including the states of NY, NJ, MS and country of Canada
Product codes and lots
Lots 2606340, 2619932, 272894A; Part # 020-848.