Recall Z-1389-2015 ยท KKX Drape, Surgical, Antimicrobial
Intuitive Surgical, Inc.
da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical equipment in various settings throughout the clinical setting.
| Date | Apr 6, 2015 (initiated Mar 16, 2015) |
| Status | Terminated |
| Reason | Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear. |
| Root cause | Packaging process control |
| Action | Firm issued field safety notice to all customers on March 16, 2015. Field safety notice includes acknowledgement form to be returned to recalling firm. A second letter was sent on May 12, 2015 to inform users that the date that the drape product unaffected by the issue will not be availalble untisl October/November 2015, not May 2015 as stated in the original communication. |
| Quantity | 442,475 total for all drape models |
| Distribution | Worldwide Distribution-Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China (including Hong Kong), Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Jap |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050322 | MICROTEK EQUIPMENT DRAPES Microtek Medical, Inc., May 17, 2005 |