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.
- Recall Initiated
- August 30, 2019
- Recall Number
- Z-0234-2020
- Quantity
- 40,475 devices
Reason for Recall
Problem with packaging sealing process which affects sterility.
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.
Lot / Code Info
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
Root Cause
Process control
Action Taken
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.