Recall Z-2130-2020— TELEFLEX MEDICAL INC

Name: FDA recall Z-2130-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-11

Class II · Ongoing

Class II FDA medical device recall by TELEFLEX MEDICAL INC, initiated 2019-10-11. It names one FDA 510(k) clearance: K911260. Product: Sprotte Needle, REF 33115131B w/ Intro 20 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, myelography/discography procedures.. Reason: 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..

Recalling firm: TELEFLEX MEDICAL INC
Classification: Class II
Status: Ongoing
Initiated: 2019-10-11
Firm location: Morrisville, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K911260 — ATRAUMATIC STANDARD SPROTTE NEEDLEPajunk GmbH·cleared 1991-10-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Sprotte Needle, REF 33115131B w/ Intro 20 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, myelography/discography procedures.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.