FDA-Device2026-10-14Class IIPACKAGING DEFECT

Polymedco SEDIPLAST blood collection tubes (S-100, S-1000) recalled for cap detachment risk

Nationwide distributionMedical devices

What this means

Certain Polymedco SEDIPLAST blood collection tubes (models S-100 and S-1000) may have a defect that causes increased resistance when a pipette is inserted. This pressure buildup can cause the tube cap to detach or be forcibly ejected, potentially exposing lab workers and work areas to blood.

  • Stop using affected SEDIPLAST tubes (lot E1150A, expiration 06/30/27).
  • Contact your facility's lab director or supervisor to identify any affected inventory.
  • Return or dispose of affected tubes according to your facility's biohazard protocols.
  • Contact Polymedco for instructions on replacement tubes or a refund.
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The agency's original wording
Hazard

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).

Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
448400
Manufactured in
510 Furnace Dock Rd, N/A, Cortlandt Manor, NY, United States
Products
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0107-2027

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