FDAAugust 30, 2019device
SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box); 2. Sprotte 22G x 120mm w/ introducer and wings (25/box); 3. Sprotte 19G x 90mm w/ introducer and wings (25/box]); 4. Sprotte 22G x 103mm w/ introducer and wings (25/box); 5. Sprotte 2...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Problem with packaging sealing process which affects sterility.
What to do
FDA enforcement status: Ongoing
Brands named
pajunk
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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