Recall Z-1546-2018 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Cardinal Health 200, LLC
Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operat
| Date | Mar 28, 2018 |
| Status | Terminated |
| Reason | products may be missing a one-way valve on the fluid patient port. |
| Root cause | Process control |
| Action | Cardinal Health sent an Urgent Product Recall letter dated March 28, 2018, Please take the following actions: 1. INSPECT your inventory for the affected product code and lot number (listed on package) 2. SEGREGATE and QUARANTINE all on-hand product 3. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652- 9648, whether or not you have affected product, indicating the product code, lot and quantity of product you've quarantined 4. CONTACT Customer Service at 800-964-5227 to arrange for return and credit of any affected product . For further questions, please call (800) |
| Quantity | 3600 units |
| Distribution | US Distribution to the state of MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.