Recall Z-0234-2020 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Pajunk GmbH
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
| Date | Aug 30, 2019 |
| Status | Open, Classified |
| Reason | Problem with packaging sealing process which affects sterility. |
| 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 |
| Quantity | 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 / N |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911260 | ATRAUMATIC STANDARD SPROTTE NEEDLE Pajunk GmbH, Oct 21, 1991 |