Sprotte Needle — Class II medical device recall Z-2129-2020
Ongoing recall by TELEFLEX MEDICAL INC, reported 2020-06-03, distributed nationwide. Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distrib
| Recall number | Z-2129-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TELEFLEX MEDICAL INC, Morrisville, NC, United States |
| Recall initiated | 2019-10-11 |
| Classified | 2020-05-26 |
| Reported by FDA | 2020-06-03 |
| Distributed | Nationwide (US) |
| Quantity | 4,227 devices |
| Reason classes | sterility |
| Lot numbers | 74A1900698, 74C1900137, 74C1900349, 74C1902955, 74E1802338, 74G1802129, 74H1802488, 74K1800901, 74K1801734, 74L1802219 |
| Model numbers | 32115130C |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2129-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.