PlainRecordsFDA · Medical device recall
Automatic Cutting Needle…
- Date posted by the FDA
- April 8, 2005
- Status
- Terminated
- Filed by
- Remington Medical Inc.
- Product
- Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005.
- Reason
- The stylet hub detaches from the stylet needle.
- Distribution pattern
- Nationwide
- Quantity
- 1737 units
- Codes and lots
- Lot number 043351 & 043272
- Recall started
- Feb. 15, 2005
- Device type
- Instrument, Biopsy
- Root cause (FDA)
- Other
- What the company told customers
- Consignees were notified by letter on 02/15/2005.
- Recall number
- Z-0697-05
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement report, recall number Z-0697-05. The agency record governs; check it and the company before acting.