—#163108

Product

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 product code: GCX — Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: a) REF 6561-910C, Lot Numbers: J802-384, J802-391 b) REF 6561-916K, Lot Number: J802-386 c) REF 6561-920C, Lot Number: J802-396

Why it was recalled

products may be missing a one-way valve on the fluid patient port.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: US Distribution to the state of MA

Timeline

Recall initiated: 2018-03-28
Terminated: 2018-11-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163108. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.