Argon Safedraw Venous Close Loop System Recalled for Pouch Seal Defect
Argon Medical Devices is recalling 10 Safedraw Venous Close Loop System blood sampling sets in Missouri due to a potential pouch seal defect that may compromise the sterile barrier.
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 involves a medical device where a defect may compromise the sterile barrier, creating a risk of harm (infection) even though no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Argon Medical Devices, Inc. is recalling 10 units of the Safedraw Venous Close Loop System, Blood Sampling Set (Model/Part Number 688695). The affected products are packaged in a tyvek bag and are intended for closed-loop blood sampling from patients without the system being exposed to the outside environment.
The recall is being issued because some of the kits may exhibit a potential defect with the pouch seal. This issue may compromise the sterile barrier of the device. The affected lot number is 204889, with an expiration date of March 2017.
The products were distributed only in Missouri. Healthcare facilities and consumers who have these specific units should stop using them and contact Argon Medical Devices for further instructions.
The recalled product
- Product
- Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from
- Manufacturer
- Argon Medical Devices, Inc
- Category
- Medical Device — Blood Sampling
- Affected units
- 10
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 (2)
- Lot Number 204889
- Expiration Date March 2017
Distribution
Distributed in 1 state:
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