Sprotte Needle — Class II medical device recall Z-2130-2020

Ongoing recall by TELEFLEX MEDICAL INC, reported 2020-06-03, distributed nationwide. Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distrib

Recall number	`Z-2130-2020`
Product type	Medical device
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	TELEFLEX MEDICAL INC, Morrisville, NC, United States
Recall initiated	2019-10-11
Classified	2020-05-26
Reported by FDA	2020-06-03
Distributed	Nationwide (US)
Quantity	800 devices
Reason classes	sterility
Lot numbers	`74A1900703`, `74D1802540`, `74E1800978`, `74F1801413`, `74G1800896`, `74H1800162`, `74K1801738`, `74K1802909`, `74L1800502`
Model numbers	`33115131B`

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2130-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.