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Open, Classified

SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;

FDA Recall Z-0107-2027 · Posted 2026-10-07

Recall StatusOpen, Classified
Product CodeJPH
Date Initiated2026-08-25
Product Quantity448400

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).

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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