# FDA recall Z-2129-2020

> **TELEFLEX MEDICAL INC** · Class II · device recall initiated 2019-10-11.

## Product

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.

## 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.

## Distribution

Nationwide distribution.

## Key facts

- **Recall number:** Z-2129-2020
- **Recalling firm:** TELEFLEX MEDICAL INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-10-11
- **Report date:** 2020-06-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Morrisville, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2129-2020

## Citation

> AI Analytics. FDA recall Z-2129-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-2129-2020. Source: US FDA. Licensed CC0.

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