—#162094

Product

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);

FDA product code: GCX — Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K042454
Affected 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;

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On about 11/17/2017 letters were sent by certified mail with tracking information to all domestic accounts and International Stryker sites were notified by email. Instructions include to inform individuals who need to be aware of the device recall, examine all stock areas and/or operating room storage for affected product quarantine and discontinue use of the recalled devices, complete the acknowledgement form, and if affected product is found contact Stryker customer service at 1-800-624-4422 (Option 3) or email endocustomersupport@stryker.com to arrange for product return.

Recalling firm

Firm: Stryker Corporation
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: Distributed domestically to . Distributed internationally to Australia and Mexico.

Timeline

Recall initiated: 2017-11-17
Terminated: 2024-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162094. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.