Recall Z-1391-2015
Intuitive Surgical, Inc. · initiated March 16, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 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.
Codes / lots: Product number 420279-03; da Vinci Si Camera Arm Drape, 20 Pack. Lot Numbers: D142175, D142175A, D142185, D142185A, D142195, D142195A, D142205, D142205A, D142215, D142215A, D142235, D142235A, D142245, D142245A, D142255, D142255A, D142265, D142265A, D142305, D142305A, D142315, D142315A, D142325, D142325A, D142335, D142335A, D142345, D142345A, D142375, D142375A, D142385, D142385A, D142395, D142395A, D142405, D142405A, D142415, D142415A, D142445, D142445A, D142455, D142455A, D142465, D142465A, D142475, D142475A, D142485, D142515, D142515A, D142525, D142525A, D142535, D142535A, D142545, D142545A, D142555, D142555A, D142585, D142585A, D142595, D142595A, D142605, D142605A, D142615, D142615A, D142625, D142635, D142655, D142655A, D142665, D142665A, D142675, D142675A, D142685, D142685A, D142695 , D142695A, D142725, D142725A, D142735, D142735A, D142745, D142745A, D142755, D142755A, D142765, D142765A, D142795, D142795A, D142805, D142805A, D142815, D142815A, D142825, D142825A, D142835, D142865, D142865A, D142875, D142875A, D142885, D142885A, D142885A, D142895, D142905, D142905A, D142915, D142935, D142935A, D142945, D142945A, D142955, D142955A, D142965, D142965A, D142975, D142975A, D142985…
Reason for recall
Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
FDA-determined cause: Packaging process control
Action taken
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.
Details
- Recall number
- Z-1391-2015
- Initiated
- March 16, 2015
- Posted by FDA
- April 6, 2015
- Terminated
- December 3, 2015
- Product code
- KKX – Drape, Surgical, Antimicrobial
- 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, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand…
- Recalling firm
- Intuitive Surgical, Inc., Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1380-2015 Class II | da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1381-2015 Class II | da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1382-2015 Class II | da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1383-2015 Class II | da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1384-2015 Class II | da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1385-2015 Class II | da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1386-2015 Class II | da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1387-2015 Class II | da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1388-2015 Class II | da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1389-2015 Class II | da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1390-2015 Class II | da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1392-2015 Class II | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1393-2015 Class II | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |