Recalls / —
—#175676
Product
Port full Access Tray Product Code: DT19330
- FDA product code
- LRP — Tray, Surgical
- Device class
- Class 1
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K021999
- Affected lot / code info
- Lot Number Expiration 2018092801 12/31/2019 2018121401 5/31/2020 2019022601 6/30/2020 2019032901 6/30/2020
Why it was recalled
Supplier initiated recall of the GRIPPER Needles
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
1. Please identify all inventory that you have within your possession and cease use immediately. 2. Complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter. Upon receipt of this record, Centurion Representative will contact you regarding retrieval of the product from your facility. 3. Please forward this recall information to any facilities to who this product may have been further distributed, instructing them to cease use immediately.
Recalling firm
- Firm
- Centurion Medical Products Corporation
- Address
- 100 Centurion Way, Williamston, Michigan 48895-9086
Distribution
- Distribution pattern
- IL
Timeline
- Recall initiated
- 2019-07-15
- Terminated
- 2020-08-31
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #175676. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.