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Device Class II · moderate Ongoing

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

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).

Recalling firmPOLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
ReasonDuring 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).
Risk classClass II (Class II · moderate)
StatusOngoing
Report dateOct 14, 2026
InitiatedAug 25, 2026
RegionNY, United States
DistributionWorldwide - 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.
Quantity448400
Code/LotModel/Catalog No. S-100 and S-1000; UDI-DI: N/A; Lot Number E1150A; Expiration Date 06/30/27
TypeVoluntary: Firm initiated
Recall numberZ-0107-2027

Official source

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