Prostate Biopsy Needle, Model: NAC-1825BB, Soxe 18 GA x 25 CM, Single use, Ethylene sterilized, Non-pyrogenic, Remington Medical, Inc., Alpharetta, GA 30005.
This recall has been terminated (originally issued March 29, 2007).
- Company
- Remington Medical Inc.
- Recall Initiated
- January 19, 2007
- Posted
- March 29, 2007
- Terminated
- May 11, 2007
- Recall Number
- Z-0673-2007
- Quantity
- 192 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Pouches were not sealed prior to sterilization.
Distribution
Nationwide.
Lot / Code Info
Lot: 063533
Root Cause
Other
Action Taken
Consignees were contacted by telephone on 01/19/2007. Each customer was informed the sterility of the product may be compromised as a result of unsealed pouches and requested to visually check their inventory.
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