Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents:
FDA device recall Z-2290-2012 · posted 2012-08-28 · Terminated
Recall details
- Recalling firm
- Unimed Surgical Products, Inc.
- Reason for recall
- On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a recall of the Medline Industries, Inc. Electrosurgical electrodes used for cutting and coagulation of soft tissue due to concerns of sterility.
- Action taken
- Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated June 4, 2010 to Medline Industries, Inc. The letter identified the affected product, problem and actions to be taken. Medline was instructed to quarantine any undistributed product and notify its customers of the recall. For further information, contact Unimed Surgical Product, Inc. by phone 800-531-2627 or FAX 800-886-1225.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 1200 each
- Distribution
- US Nationwide Distribution - including the state of IL.
- Date initiated
- 2010-06-16
- Date posted
- 2012-08-28
- Date terminated
- 2012-08-30
- Location
- Largo, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE (K962935) | Unimed Surgical Products, Inc. | 1996-09-03 |
| NEEDLE ELCTRODE (K944265) | Unimed Surgical Products, Inc. | 1995-05-05 |