Lower risk Medical device recall · FDA · Published October 11, 2019

Teleflex Sprotte Lumbar Puncture Needles Recall: Packaging Issue Risk

Teleflex Medical recalls Sprotte lumbar puncture needles with specific batch numbers due to potential packaging issues that may compromise sterility. Affected users should contact Teleflex for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2129-2020Medical device Teleflex Medical ›

Lower-risk 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.

Take action

Contact the company

Recalling firmTELEFLEX MEDICAL INC3015 Carrington Mill Blvd · Morrisville, NC 27560-5437

✎ GovInfoNow plain-language explainer

Teleflex Medical is recalling certain batches of Sprotte lumbar puncture needles because the packaging might not be sterile. This could lead to infections if the needles are used without proper sterility. Read more at govinfonow.com/recall/66804-teleflex-sprotte-lumbar-puncture-needles-recall-packaging-issue-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66804-teleflex-sprotte-lumbar-puncture-needles-recall-packaging-issue-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2129-2020

Cite this page

“Teleflex Sprotte Lumbar Puncture Needles Recall: Packaging Issue Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66804-teleflex-sprotte-lumbar-puncture-needles-recall-packaging-issue-risk. Based on FDA recall #Z-2129-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2129-2020%22&limit=1).

The FDA announced on 2019-10-11 that Teleflex Medical is recalling Sprotte lumbar puncture needles distributed nationwide because Pajunk identified a packaging issue that may compromise sterility. The agency issued recall number Z-2129-2020 for the Class II voluntary recall.

How to tell if you have it

Brand: Teleflex Medical
Product: Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5"
Lot/Batch Numbers: 74A1900698, 74C1902955, 74C1900349, 74C1900137, 74E1802338, 74G1802129, 74H1802488, 74K1800901, 74K1801734, 74L1802219
Units affected: 4227 devices

The hazard

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.

Context

GovInfoNow's records show Teleflex Medical has had 11 other recalls since 2019-12-13. Other recent recalls include the Teleflex Flex Tube and Smooth-Flo Flex Tubes Recall (2022-04-11), the Arrow Percutaneous Thrombolytic Device Recall (2022-01-11), and the Teleflex Polaris Laryngoscope Recall (2021-02-18). Other recent recalls of similar products include Medline Convenience Kits Recall: Potential Sterility Breach in Packaging (2026-06-12) and Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (2026-06-12).

How to tell if you have this one

Check the batch numbers on the packaging: 74A1900698, 74C1902955, 74C1900349, 74C1900137, 74E1802338, 74G1802129, 74H1802488, 74K1800901, 74K1801734, 74L1802219. The needles are labeled as Sprotte 22G x 3.5" with the reference number 32115130C.

Brand
Teleflex Medical
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-2129-2020	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, myelography/discography procedures.; Lot/Batch Numbers: 74A1900698, 74C1902955, 74C1900349, 74C1900137, 74E1802338, 74G1802129, 74H1802488, 74K1800901, 74K1801734, 74L1802219	4227 devices
Z-2130-2020	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.; Lot/Batch Numbers: 74A1900703, 74D1802540, 74E1800978, 74F1801413, 74G1800896, 74H1800162, 74K1801738, 74K1802909, 74L1800502	800 devices

Based on the official FDA remedy

What to do — step by step

Check Batch Numbers
Look for the batch numbers listed: 74A1900698, 74C1902955, 74C1900349, 74C1900137, 74E1802338, 74G1802129, 74H1802488, 74K1800901, 74K1801734, 74L1802219 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 8 months after the firm started it.

Oct 11, 2019Firm started the recall
May 26, 2020FDA classified it Class II
Jun 3, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/66804-teleflex-sprotte-lumbar-puncture-needles-recall-packaging-issue-risk">Teleflex Sprotte Lumbar Puncture Needles Recall: Packaging Issue Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2129-2020 (October 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2129-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.