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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Pajunk GmbH
- 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
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