Recall Z-2129-2020 ยท BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
TELEFLEX MEDICAL INC
Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical 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.
| Date | Oct 11, 2019 |
| Status | Open, Classified |
| Reason | Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches. |
| Root cause | Process control |
| Action | The firm, Teleflex Medical, initiated the recall by letter on 10/11/2019. The notice requested that the consignees take actions as follows: Distributors: 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed in the letter. 2. Using the provided customer letter and recall acknowledgement form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for co |
| Quantity | 4227 devices |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911260 | ATRAUMATIC STANDARD SPROTTE NEEDLE Pajunk GmbH, Oct 21, 1991 |