Windstone Medical Packaging Recalls General Pack II Surgical Kits
Windstone Medical Packaging is recalling General Pack II surgical kits because the Medtronic gloves included may contain splits or holes that compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves compromised sterility in surgical gloves, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 135 units of General Pack II, Kit number CMP1812(B), which are convenience custom kits used for general surgery in hospital operating rooms. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, included in the custom AMS kit. The gloves may contain splits or holes that compromise sterility.
The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The specific lot numbers and expiration dates involved are 59655 (7/11/2015), 65453 (11/3/2015), 66602 (11/28/2015), 62302 (1/7/2016), and 57319 (6/27/2016).
Hospitals and medical facilities should stop using these kits and contact the recalling firm for instructions on return or disposal. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- General Pack II, Kit number CMP1812(B convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 135
Distribution
Part of a larger recall action
This product is one of 150 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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