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
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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
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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 |
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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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