CLASS II ONGOING Device recall · Reported 3 Jun 2020 · FDA Enforcement Report

Sprotte Needle recalled by Teleflex Medical

Teleflex Medical is recalling Sprotte Needle, distributed nationwide in the US. The recall was initiated on 11 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot/Batch Numbers: 74A1900703, 74D1802540, 74E1800978, 74F1801413, 74G1800896, 74H1800162, 74K1801738, 74K1802909, 74L1800502

Quantity recalled800 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2130-2020
FDA event ID: 85551
Recalling firm: Teleflex Medical, Morrisville, NC
Classification: Class II
Status: Ongoing
Recall initiated: 11 Oct 2019
FDA classified: 26 May 2020
Reported: 3 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Spinal Implants

Timeline

11 Oct 2019	Recall initiated by company
26 May 2020	Classified by FDA	+228 days
3 Jun 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot/Batch Numbers: 74A1900703, 74D1802540, 74E1800978, 74F1801413, 74G1800896, 74H1800162, 74K1801738, 74K1802909, 74L1800502

Where was it sold?

Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 85551

This product is part of a recall event; the main page for the event is Sprotte Needle recalled by Teleflex Medical.

Reported	Class	Recall	Company	Reason	Where
3 Jun 2020	CLASS II	Sprotte Needle recalled by Teleflex Medical	Teleflex Medical	Sterility	Nationwide

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