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U.S. Department of Health and Human Services

Class 2 Device Recall MediVac(TM) Flex Advantage(TM) Suction Canister Liner

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  Class 2 Device Recall MediVac(TM) Flex Advantage(TM) Suction Canister Liner see related information
Date Initiated by Firm March 28, 2018
Create Date April 30, 2018
Recall Status1 Terminated 3 on November 29, 2018
Recall Number Z-1546-2018
Recall Event ID 79702
Product Classification Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
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).
Code Information 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
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information Contact Customer Advocacy
800-292-9332
Manufacturer Reason
for Recall		 products may be missing a one-way valve on the fluid patient port.
FDA Determined
Cause 2		 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) 292- 9332.
Quantity in Commerce 3600 units
Distribution US Distribution to the state of MA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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