Stryker Corporation: STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (

Is my product affected?

STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);

• UPC 07613327061499
• UPC 07613327061659

Check against the official notice below — it lists the full affected range.

What happened

Stryker Corporation is recalling Stryker CASSETTE PUMP AHTO Tube Sets that are labeled as sterile. The recall involves two models: Model 0250070600 and Model 0250070620, affecting a total of 60,753 units distributed domestically in the United States and internationally to Australia and Mexico. Routine bioburden testing of certain lots found microbial contamination levels higher than Stryker's internal acceptable rates.

The affected products are identified by specific lot numbers associated with each model. Model 0250070600 lots include 17284FG2, 17291FG2, and 17300FG2. Model 0250070620 includes lots 17275FG2, 17279FG2, 17280FG2, 17282FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17291FG2, 17292FG2, 17293FG2, 17297FG2, 17298FG2, and 17299FG2. The source does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.

Details from the source

Reason for recall: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. Distribution: Distributed domestically to . Distributed internationally to Australia and Mexico. Quantity: 60,753 units total Lot/code info: a. Model 0250070600, UDI 07613327061499, Lot No. 17284FG2, 17291FG2, 17300FG2; b. Model 0250070620, UDI 07613327061659, Lot No. 17275FG2, 17279FG2, 17280FG2, 17282FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17291FG2, 17292FG2, 17293FG2, 17297FG2, 17298FG2, 17299FG2;

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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