FDA Recall
Terminated
Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy Needle
Recall: Z-1935-2009
·
Initiated June 19, 2009
Recall
- Recall Number
- Z-1935-2009
- Event Number
- 52781
- Firm
- Remington Medical Inc.
- FEI Number
- 1000132370
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- June 19, 2009
- Posted
- September 20, 2009
- Terminated
- October 23, 2009
- Address
- 6830 Meadowridge Ct., Alpharetta, GA, 30005
Description
Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy Needle
Reason
Two unsealed pouches were identified after product release, compromising product sterility.
Action
Initial notification to consignees was issued via telephone on June 19, 2009 and by certified mail on June 30, 2009. They were instructed to examine their inventory and quarantine product subject to the recall. If the product was further distributed, they were advised to identify their customers and notify them at once of the recall via the recall letter. A Return Authorization number was provided. Forty of 50 units in distribution were returned from the two customers.
Distribution
US - CA and WI.
Quantity
50 units