Recall Z-0204-2017— Windstone Medical Packaging, Inc.
Class II · Terminated
Class II FDA medical device recall by Windstone Medical Packaging, Inc., initiated 2015-04-22, terminated 2016-10-25. FDA's recall record names no specific 510(k) clearance for this event. Product: Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room. Reason: The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility..
- Recalling firm
- Windstone Medical Packaging, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-22
- Terminated
- 2016-10-25
- Firm location
- Billings, MT, United States
Product description
Hand Pack, Kit number 009651-3, AMS1371(B, AMS1539, AMS1539(A, AMS3640, AMS3847, AMS4213, AMS4311, PSS1843(A, PSS2153(B, PSS2187(B, PSS2351, and PSS3073. convenience custom kits used for general surgery in hospital operating room
Reason for recall
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.