CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) N
FDA device recall Z-1400-2015 · posted 2015-04-08 · Terminated
Recall details
- Recalling firm
- Civco Medical Instruments Inc
- Reason for recall
- Leaks were detected in the recalled lot which may compromise the sterility of the product.
- Action taken
- On 3/12/2015, the Urgent Medical Device Recall notice was emailed to all of the affected customers. The notice identified the affected product and stated that the sterile covers from the affected manufacturing lot were not meeting quality levels and may leak. Customers were requested to return all of surgi tip covers from the production lot identified for replacement. To schedule the return and arrange for replacement product to be sent, customers were asked to contact Ms. Amy King, Customer Service Team Leader at 319-248-6520 or info@civco.com.
- Root cause
- Process design
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 120 pouches
- Distribution
- Distributed to the states of CA, IL, MA, MI, MO, and WI.
- Date initiated
- 2015-02-26
- Date posted
- 2015-04-08
- Date terminated
- 2017-02-28
- 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 |