Recall Z-0835-2018
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
StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
Codes / lots: a. Model 0250070500, Product Code GCJ, UDI 07613327061390, Lot No. 17275FG2, 17276FG2, 17277FG2, 17278FG2, 17279FG2, 17280FG2, 17283FG2, 17284FG2, 17285FG2, 17286FG2, 17289FG2, 17290FG2, 17291FG2, 17292FG2, 17293FG2, 17294FG2, 17297FG2, 17299FG2, 17301FG2); 0250070505, 0250070520; b. Model 0250070505, Product Code GCX, UDI 07613327061406, Lot No. 17294FG2; c. Model 0250070520, Product Code GCX, UDI 07613327061369, Lot No. 17282FG2, 17283FG2, 17286FG2, 17289FG2, 17290FG2, 17292FG2, 17293FG2, 17294FG2, 17296FG2, 17297FG2, 17298FG2, 17299FG2, 17300FG2, 17301FG2, 17302FG2
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-0835-2018
- Initiated
- November 17, 2017
- Terminated
- January 29, 2024
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- 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-0836-2018 Class II | STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a.…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 |