Recall Z-0836-2018
Stryker Corporation · initiated November 17, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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);
Codes / lots: 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;
Reason for recall
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0836-2018
- Initiated
- November 17, 2017
- Terminated
- January 29, 2024
- Product code
- GCX – Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- Quantity
- 60,753 units total
- Distribution
- Distributed domestically to . Distributed internationally to Australia and Mexico.
- Recalling firm
- Stryker Corporation, San Jose, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0835-2018 Class II | StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC…Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. | 11/17/2017Terminated |
| Z-0837-2018 Class II | STRYKER WEDGE INTERFERENCE SCREW SYSTEM, ACL Interface Screw, 9MM X 25MM, Model…Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. | 11/17/2017Terminated |
| Z-0838-2018 Class II | ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.… | 11/17/2017Terminated |