FDA Device recall Z-2130-2020
Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gai…
- FDA Device
- Class II
- ongoing
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class II recall of Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gai… by Teleflex Medical, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2130-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-10-11 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Teleflex Medical |
| Distribution | US |
Product
Sprotte Needle, REF 33115131B w/ Intro 20 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
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.
Identifiers
| code_info | Lot/Batch Numbers: 74A1900703, 74D1802540, 74E1800978, 74F1801413, 74G1800896, 74H1800162, 74K1801738, 74K1802909, 74L1800502 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2130-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.