CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with att
FDA device recall Z-2242-2010 · posted 2010-08-20 · Terminated
Recall details
- Recalling firm
- Civco Medical Instruments Inc
- Reason for recall
- Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover.
- Action taken
- CIVCO sent a "Urgent - Medical Device Correctdion" letter date July 19, 2010 to consignees describing the reason for recall and requesting they dispose of the affect lot number of product. A response form was enclosed for completion and return to the firm, indicating the amount of product in inventory and requesting a Return Authorization Number. The form was to be returned via FAX or e-mail. Customers may contact CIVO at 800-445-6741.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 22 boxes
- Distribution
- Nationwide distribution: the states of OH, MD, NE, VA, IA, MI, WA, and WI.
- Date initiated
- 2010-07-20
- Date posted
- 2010-08-20
- Date terminated
- 2012-04-13
- Location
- Kalona, IA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER (K013721) | CIVCO Medical Instruments Co., Inc. | 2001-12-28 |