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Open, Classified

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.

FDA Recall Z-0234-2020 · Posted None

Recalling FirmPajunk GmbH
Recall StatusOpen, Classified
Product CodeBSP
Date Initiated2019-08-30
Product Quantity40,475 devices

Reason for Recall

Problem with packaging sealing process which affects sterility.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K911260ATRAUMATIC STANDARD SPROTTE NEEDLEPajunk GmbH · 1991-10-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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