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SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/ introduce...

FDA Device Recall #Z-0234-2020 — Class II — August 30, 2019

Recall Summary

Recall Number Z-0234-2020
Classification Class II — Moderate risk
Date Initiated August 30, 2019
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pajunk GmbH
Location Geisingen
Product Type Devices
Quantity 40,475 devices

Product Description

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 for Recall

Problem with packaging sealing process which affects sterility.

Distribution Pattern

Worldwide distributions - US Nationwide including the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, RI, SC, TN, TX, WI, WY. Countries of Germany, Ellada / Greece, Canada, Italy, Lietuva / Lithuania/ Litauen, Australia, Luxembourg, Austria, Nederland / Netherlands, Belgium, Polska / Poland, Switzerland, Sverige / Sweden, Czech Republic, Slovenija / Slovenia, Danmark / Denmark, Kroatien/ Croatia, Espa¿a / Spain, Aserbeidschan/ Azerbaidzan, Suomi / Finland, Brunei, France, Russland/ Russia, Great Britain, Oman, Israel.

Lot / Code Information

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

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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