Z-1381-2015Class II
da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be...
Intuitive Surgical, Inc. / initiated 2015-03-16 / Terminated / root cause: packaging
Intuitive Surgical, Inc. began a recall of da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment Drapes are to be used to cover a variety of surgical and non-surgical... on . FDA classified it as Class II and gives the reason as "Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1381-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Intuitive Surgical, Inc.
- Product
- da Vinci S Surgical System IS2000, 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.
- Product code
- KKX Drape, Surgical, Antimicrobial
- Reason for recall
- Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to tear.
- Root cause tag
- packaging
- FDA 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 in commerce
- 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, Egypt, Finland, France, France, Germany, Greece, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Mauritius, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam.
- Product codes and lots
- Product number 400016-04; da Vinci (Standard System) Camera Arm Drape, 20 Pack. Lot Numbers for Cloudy/Waxy issue: ALL lot numbers Lot Numbers for Tear issue: None
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1380-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1381-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1382-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1383-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1384-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1385-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1386-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1387-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1388-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1389-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1390-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1391-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1392-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1393-2015 | Class II | Terminated | Voluntary: Firm initiated |
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