Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
FDA Device Recall #Z-1544-2020 — Class II — February 10, 2020
Recall Summary
| Recall Number | Z-1544-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 10, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries Inc |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 1,541,532 units |
Product Description
Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration 06/30/2022.
Reason for Recall
Voids were discovered in the packaging seal and loss of sterility on the outside of the contents within the Tyvek Form-Fill-Seal packaging.
Distribution Pattern
US Nationwide: MA, LA, IL, MO, MI, MN, NJ, KS, GA, NY, PA, SD, CT, TN, MD, OH, VA, FL, TX, KY, CO, IN, AL, CA, MT, OR, AK, AL, DC, IA, ME, NV, NE, SC, WV, WY, RI, NC, AZ, UT, DE and WI.
Lot / Code Information
REF DYND70288 2/PK Expiration 06/30/2022
Other Recalls from Medline Industries Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0358-2022 | Class II | EVLP Convenience Pack/Kit | Oct 27, 2021 |
| Z-0362-2022 | Class II | Bedside PICC CDS Convenience Kit | Oct 27, 2021 |
| Z-0360-2022 | Class II | Major Vascular CDS Convenience Kit | Oct 27, 2021 |
| Z-0359-2022 | Class II | Neuro Convenience Kit | Oct 27, 2021 |
| Z-0361-2022 | Class II | Venous Access Pack-LF Convenience Kit | Oct 27, 2021 |
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.