The Recall Desk
HighFDA (Devices)·Z-0234-2020·Announced 2019-11-06

Pajunk Sprotte Lumbar Puncture Needles Recalled for Sterility Concerns

Pajunk GmbH is recalling Sprotte Lumbar Puncture Needles because a packaging sealing issue may affect sterility. The recall covers 40,475 devices distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (loss of sterility) for a medical device used in invasive procedures, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Pajunk GmbH is recalling Sprotte Lumbar Puncture Needles with Introducer due to a problem with the packaging sealing process that affects sterility. The affected products include various gauges and lengths (19G, 20G, 21G, and 22G) with item numbers 321151-30C, 331151-30C, 321151-31C, 341151-30C, 321151-31A, 341151-31A, 341151-31B, and 331151-31B. The recall involves 40,475 devices from lot numbers 1240 through 1313.

These devices are intended for diagnostic lumbar puncture, myelography, and discography procedures in adult and pediatric patients. The recall covers worldwide distribution, including the United States and numerous countries in Europe, Asia, and the Middle East.

Healthcare providers and consumers should stop using the affected devices and contact Pajunk GmbH for further instructions.

The recalled product

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/ introd
Manufacturer
Pajunk GmbH
Category
Medical Device — Surgical Instruments
Hazard
Affected units
40,475

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • Lot Numbers 1240 through 1313. Item numbers: 1. 321151-30C
  • 2. 331151-30C
  • 3. 321151-31C
  • 4. 341151-30C
  • 5. 321151-31A
  • 6. 341151-31A
  • 7. 341151-31B
  • 8. 331151-31B

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Related recalls

Same hazard · sterility

See all →