AccessClosure Recalls MynxGrip Vascular Closure Devices Due to Packaging Errors
AccessClosure is recalling 70 MynxGrip Vascular Closure Devices shipped with improper transport and packaging configurations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a packaging/transport error without reported injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
AccessClosure, Inc., a Cardinal Health Company, is recalling 70 units of the 6F/7F MynxGrip Vascular Closure Device, Model MX6721. The recall involves two specific lots: Lot No. F1609702 (Expiry 4/20/2018) and Lot No. F1534302 (Expiry 12/31/2016). The devices were distributed in California and Mississippi.
The recall was initiated because the devices were shipped from a distributor using improper transport and packaging configurations. The MynxGrip device is indicated for sealing femoral arterial and venous access sites in patients who have undergone diagnostic or interventional endovascular procedures.
Healthcare facilities and distributors should stop using the affected devices and contact AccessClosure for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip Vascular Closure Device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have underg
- Manufacturer
- AccessClosure, Inc., A Cardinal Health Company
- Hazard
- Affected units
- 55
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot No: F1609702
- Expiry 4/20/2018
- Lot No. F1534302
- Expiry 12/31/2016
Distribution
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