Class 2 Device Recall SEDIPLAST

• Date Initiated by Firm: August 25, 2026
• Date Posted: October 07, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0107-2027
• Recall Event ID: 99810
• 510(K)Number: K840500
• Product Classification: Test, erythrocyte sedimentation rate - Product Code JPH
• Product: SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000
• Code Information: Model/Catalog No. S-100 and S-1000; UDI-DI: N/A; Lot Number E1150A; Expiration Date 06/30/27
• FEI Number: 1000119795
• Recalling Firm/ Manufacturer: POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC; 510 Furnace Dock Rd; Cortlandt Manor NY 10567-6220
• For Additional Information Contact: Mariah Nieves; +1-914-2930924
• Manufacturer Reason for Recall: During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting in the release of blood and exposure of the operator or surrounding work area to a biological hazard (blood).
• FDA Determined Cause: Process control
• Action: On August 26, 2026, URGENT PRODUCT RECALL letters were sent to customers. ACTIONS REQUIRED: 1. Examine your inventory and identify all Sediplast Westergren ESR tubes from Lot E1150A. 2. Immediately discontinue use and quarantine all unused tubes from the affected lot. 3. If affected product was distributed to other facilities or locations, immediately forward this notification to those recipients. 4. Contact Polymedco Technical Services to arrange replacement of the affected product and obtain instructions for its return or disposal. 5. Complete and return the enclosed Customer Recall Response Form to Polymedco within five business days, even if you no longer have any affected product in inventory. 6. If affected tubes were previously used without an incident, no additional action is required. If a cap-ejection, blood-spray or exposure incident occurred, follow your facility s applicable biohazard-exposure procedures and report the incident to Polymedco Technical Services. Please do not discard quarantined product until you have received return or disposal instructions from Polymedco.
• Quantity in Commerce: 448400
• Distribution: Worldwide - US Nationwide distribution in the states and territory of AK, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and the country of United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JPH