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

Class II
Recalling firm
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
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).
Affected products (lot / model / serial)
Model/Catalog No. S-100 and S-1000; UDI-DI: N/A; Lot Number E1150A; Expiration Date 06/30/27
Units affected
448400
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.
Firm location
Cortlandt Manor, NY, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
E-Mail
Product type
Devices
Status
Ongoing
Recall number
Z-0107-2027
Recall initiated
August 25, 2026
FDA classification date
October 7, 2026
FDA report date
October 14, 2026
FDA event ID
99810
Last updated on HTM Vibe
October 21, 2026
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