Z-0234-2020Class II

SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings...

Name: Z-0234-2020 SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings...
Creator: Pajunk GmbH
Published: 2019-08-30
License: https://open.fda.gov/license/

Pajunk GmbH Medizintechnologie / initiated 2019-08-30 / Open, Classified / root cause: manufacturing process

FDA source

Pajunk GmbH began a recall of 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... on 2019-08-30. FDA classified it as Class II and gives the reason as "Problem with packaging sealing process which affects sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0234-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-08-30
Posted: 2019-10-29
Recalling firm: Pajunk GmbH Medizintechnologie
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.
Product code: BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Reason for recall: Problem with packaging sealing process which affects sterility.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Pajunk GmbH Medizintechnologie notified distributor and end customers on about 08/30/2019, via "Urgent Product Recall Notice" letters. Instructions included to immediately identify any affected products in inventory and quarantine them, cease use of affected products, and complete and return the Attachment B indicating receipt of the notice. Additionally end customers and distributors were instructed to provide the recall notice to all responsible personnel within the organization or if products were further distributed. Questions or concerns can be directed to Laura Roberts, Manager of Office of Operations and Client Relations, email [email protected], phone (470) 448-4075.
Quantity in commerce: 40,475 devices
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0234-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0234-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-11-06	2019-10-29

Product code BSP

K911260Class IIAtraumatic Standard Sprotte NeedlePajunk GmbH / cleared 1991-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)