FDAOctober 11, 2019device
Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myel...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.
What to do
FDA enforcement status: Ongoing
Brands named
teleflex medicalteleflex
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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