Medline Aortic Graft Kits Recalled for Non-Detectable Sponge Component
Medline Industries is recalling 45 aortic graft kits in Canada because the included sponge is not x-ray detectable.
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 with a defect (non-x-ray detectable sponge) that poses a risk of harm (retained foreign body) in a high-risk setting (surgery), but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medline Industries Inc is recalling 45 units of the Greffe Aorte-LF (Model DYNJ31877F) aortic graft convenience kit. The recall is limited to foreign distribution in Canada. The affected lots are 20FBW645 and 20HBM397, both with an expiration date of 02/28/2022.
The recall was initiated because the cylindrical sponge component included in the kit is not x-ray detectable. This product is used in various surgeries, including cardiac, abdominal, and neck procedures. The lack of x-ray detectability poses a risk if the sponge is inadvertently retained in a patient during surgery, as it may not be easily identified via imaging.
Healthcare providers and facilities that have received these specific lots should stop using the product and contact Medline Industries for instructions on return or disposal. Consumers are not directly affected as this is a professional medical device distributed to healthcare facilities.
The recalled product
- Product
- Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Surgical Kits
- Affected units
- 45
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 20FBW645 (Expiration: 02/28/2022)
- Lot 20HBM397 (Expiration: 02/28/2022)
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Medline Industries 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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