Waste Management Kit. Catalog Number K10-04381AP
FDA device recall Z-0633-2017 · posted 2016-11-19 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
- Action taken
- Consignees notified via letter on 09/23/16 to quarantine any devices and discontinue use, ensure all personnel to whom the devices were distributed are made aware of the field action, and return affected devices to Merit Medical.
- Root cause
- Process control
- Status
- Terminated
- Product code
- OJV
- Quantity affected
- 30 units
- Distribution
- Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
- Date initiated
- 2016-09-23
- Date posted
- 2016-11-19
- Date terminated
- 2017-03-27
- Location
- South Jordan, UT
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