Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose aspiration Cytology Biopsy Needle
This recall has been terminated (originally issued September 20, 2009).
- Company
- Remington Medical Inc.
- Recall Initiated
- June 19, 2009
- Posted
- September 20, 2009
- Terminated
- October 23, 2009
- Recall Number
- Z-1935-2009
- Quantity
- 50 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Two unsealed pouches were identified after product release, compromising product sterility.
Distribution
US - CA and WI.
Lot / Code Info
Lot number 091386.
Root Cause
Process control
Action Taken
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.
More recalls by Remington Medical Inc.
Remington MEDICAL Drainage Bag, REF 600-D;
Dec 5, 2023
FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down.
Electrical extension cable...
Apr 9, 2014