# FDA recall Z-0234-2020

> **Pajunk GmbH** · Class II · device recall initiated 2019-08-30.

## Product

SPROTTE Lumbar with Introducer, labeled as the following:      1. Sprotte 22G x 90mm w/ introducer and wings (25/box);      2. Sprotte 22G x 120mm w/ introducer and wings (25/box);      3. Sprotte 19G x 90mm w/ introducer and wings (25/box]);      4. Sprotte 22G x 103mm w/ introducer and wings (25/box);      5. Sprotte 21G x 90mm w/ introducer and wings (25/box);      6. Sprotte 21G x 103mm w/ introducer and wings (25/box);      7. Sprotte 20G x 103mm w/ introducer and wings (25/box);      8. Sprotte 20G x 90mm w/ introducer and wings (25/box)    Product Usage: 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. The device is intended for adult and pediatric patients.

## Reason for recall

Problem with packaging sealing process which affects sterility.

## Distribution

Worldwide distributions - US Nationwide including the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, RI, SC, TN, TX, WI, WY.      Countries of Germany, Ellada / Greece, Canada, Italy, Lietuva / Lithuania/ Litauen, Australia, Luxembourg, Austria, Nederland / Netherlands, Belgium, Polska / Poland, Switzerland, Sverige / Sweden, Czech Republic, Slovenija / Slovenia, Danmark / Denmark, Kroatien/ Croatia, Espa¿a / Spain, Aserbeidschan/ Azerbaidzan, Suomi / Finland, Brunei, France, Russland/ Russia, Great Britain, Oman, Israel.

## Key facts

- **Recall number:** Z-0234-2020
- **Recalling firm:** Pajunk GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-08-30
- **Report date:** 2019-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Geisingen, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0234-2020

## Citation

> AI Analytics. FDA recall Z-0234-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0234-2020. Source: US FDA. Licensed CC0.

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