Recall Z-1400-2015 ยท ITX Transducer, Ultrasonic, Diagnostic
Civco Medical Instruments Inc
CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Individual Tyvek pouches are packaged as a box of 12. Rx only. The cover allows use of the transducer in scanning and needle guided procedures for body surface, endocav
| Date | Apr 8, 2015 (initiated Feb 26, 2015) |
| Status | Terminated |
| Reason | Leaks were detected in the recalled lot which may compromise the sterility of the product. |
| Root cause | Process design |
| Action | 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. |
| Quantity | 120 pouches |
| Distribution | Distributed to the states of CA, IL, MA, MI, MO, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013721 | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER CIVCO Medical Instruments Co., Inc., Dec 28, 2001 |