Recall Z-2486-2018 ยท GBX Catheter, Irrigation
Cardinal Health 200, LLC
Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Cassette, 5mm x 33cm Composite Probe, Single Spike, Ref ASC1200, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
| Date | Jun 11, 2018 |
| Status | Terminated |
| Reason | The suction valve may not close properly which could cause continuous suction. |
| Root cause | Device Design |
| Action | The recalling firm issued letters dated 6/11/2018 via FedEx Next Day Priority Mail requesting return of the product. |
| Quantity | A total of 63,020 valves were distributed. Specific product quantities were not provided. |
| Distribution | Distribution was made to AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MT, NC, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, and WY. Government and military distribution was also made. Foreign distribution was made to Belgium, France, Germany, Israel, Italy, Netherl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.