FDA Device recall Z-0234-2020
SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box)
- FDA Device
- Class II
- ongoing
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introducer and wings (25/box) by Pajunk, citing problem with packaging sealing process which affects sterility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0234-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-08-30 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Pajunk |
| Distribution | US |
Product
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.
Reason
Problem with packaging sealing process which affects sterility.
Identifiers
| code_info | Lot Numbers 1240 through 1313. Item numbers: 1. 321151-30C; 2. 331151-30C; 3. 321151-31C; 4. 341151…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 |
|---|
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-0234-2020%22
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