Recall Z-2242-2010 ยท ITX Transducer, Ultrasonic, Diagnostic
Civco Medical Instruments Inc
CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers and prevent cross-contamination from occurring with equipment and patients.
| Date | Aug 20, 2010 (initiated Jul 20, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 22 boxes |
| Distribution | Nationwide distribution: the states of OH, MD, NE, VA, IA, MI, WA, 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 |