Reported Nov 6, 2019 · Ongoing
SPROTTE Lumbar with Introducer, labeled as the following
Pajunk GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Pajunk GmbH · Karl-hall-str. 1 · Geisingen · N/A
Is this the product you have?
SPROTTE Lumbar with Introducer, labeled as the following
8 of 8 products
| # | Product as published |
|---|---|
| 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. |
- Lot codes and dates
- Lot Numbers 1240 through 1313
- Item numbers
1. 321151-30C2. 331151-30C3. 321151-31C4. 341151-30C5. 321151-31A6. 341151-31A7. 341151-31B8. 331151-31B
- Amount recalled
- 40,475 devices
Where it was sold
Why it was recalled
Problem with packaging sealing process which affects sterility.
This product could cause temporary or reversible health problems — stop using it.
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