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U.S. Department of Health and Human Services

Class 2 Device Recall The SPROTTE lumbar

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  Class 2 Device Recall The SPROTTE lumbar see related information
Date Initiated by Firm August 30, 2019
Create Date October 29, 2019
Recall Status1 Open3, Classified
Recall Number Z-0234-2020
Recall Event ID 83714
510(K)Number K911260  
Product Classification Needle, conduction, anesthetic (w/wo introducer) - Product Code BSP
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.
Code Information 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
Recalling Firm/
Manufacturer		 Pajunk GmbH
Karl-hall-str. 1
Geisingen Germany
Manufacturer Reason
for Recall		 Problem with packaging sealing process which affects sterility.
FDA Determined
Cause 2		 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 Laura.roberts@pejunk-usa.com, 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = BSP and Original Applicant = PAJUNK GMBH
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