da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover
FDA device recall Z-1381-2015 · posted 2015-04-06 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 442,475 total 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, Egy
- Date initiated
- 2015-03-16
- Date posted
- 2015-04-06
- Date terminated
- 2015-12-03
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICROTEK EQUIPMENT DRAPES (K050322) | Microtek Medical, Inc. | 2005-05-17 |