Hemashield Gold Knitted Bifurcated Vascular Graft Mislabeling Recall
Maquet Cardiovascular is recalling Hemashield Gold vascular grafts due to probable mislabeling. A different graft product may have been packaged in the carton.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall involving medical device mislabeling with potential for patient harm if an incorrectly-sized vascular graft were implanted. No illnesses or injuries are reported in the source.
Plain-English summary
Maquet Cardiovascular, LLC is recalling Hemashield Gold Knitted Bifurcated vascular grafts (18 mm x 9 mm, reference number M002020851890). Two units with serial numbers 1260004700 and 1259882880 in lot 20C04 are affected.
The recall is due to probable mislabeling. A Hemashield Platinum Woven Double Velour Bifurcated Vascular Graft (24 mm x 12 mm, different specifications) may have been packaged in the carton instead of the intended product. If the mislabeled product was implanted, the incorrect graft size could pose a risk to patient health.
The affected products were distributed nationwide in Illinois and North Carolina.
The recalled product
- Product
- Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
- Manufacturer
- Maquet Cardiovascular, LLC
- Category
- Medical Device — Vascular Graft
- Hazard
- Affected units
- 2
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: 20C04
- Serial Numbers: 1260004700 and 1259882880
Distribution
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