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-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).
FDA Recall Z-1546-2018 · Posted None
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Recalling FirmCardinal Health 200, LLC
Recall StatusTerminated
Product CodeGCX
Date Initiated2018-03-28
Date Terminated2018-11-29
Product Quantity3600 units
Reason for Recall
products may be missing a one-way valve on the fluid patient port.
Firm 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) 292- 9332.
Root Cause
Process control
Distribution Pattern
US Distribution to the state of MA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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