Recall Z-1728-2019 ยท HIF Insufflator, Laparoscopic
Stryker Corporation
Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP), REF 0620-040-690, an accessory to the PNEUMO SURE High Flow Insufflator, Disposable, Rx, Sterile.
| Date | Mar 7, 2019 |
| Status | Terminated |
| Reason | The heated tube sets were consistently leaking and detaching from the cassette. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters dated 3/7/2019 via certified mail on 3/7/2019. A second letter dated 3/7/2019 was issued on 4/15/2019 via certified mail to two customers which included an additional lot number for one of the products. |
| Quantity | 19,083 boxes |
| Distribution | Distribution was nationwide to medical facilities. There was government/military distribution. Foreign distribution was made to Argentina, Brazil, Canada, Chile, Colombia, (EMEA-no specific address/country listed), India, Japan, Latin America (no country listed), Mexico, Saudi Arabia, UAE, and Ur |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003792 | STRYKER HEATED INSUFFLATOR TUBE SET Stryker Corp., Feb 21, 2001 |