Chiba Needle Marked Model: CNM-2308, Size: 23 GA x 20 CM, Remington Medical, Inc., Alpharetta, GA 30005. General purpose
FDA device recall Z-1935-2009 · posted 2009-09-20 · Terminated
Recall details
- Recalling firm
- Remington Medical Inc.
- Reason for recall
- Two unsealed pouches were identified after product release, compromising product sterility.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Quantity affected
- 50 units
- Distribution
- US - CA and WI.
- Date initiated
- 2009-06-19
- Date posted
- 2009-09-20
- Date terminated
- 2009-10-23
- Location
- Alpharetta, GA
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