VIA Medical Collection Bag; The collection bag is an accessory waste bag used in conjunction with the sterile LVM blood
FDA device recall Z-1531-2013 · posted 2013-06-11 · Terminated
Recall details
- Recalling firm
- International Biomedical, Ltd.
- Reason for recall
- International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end user. To alleviate the occurrence of this issue in the fixture, the connector on the collection bag has been improved to
- Action taken
- International Biomedical decided to recall and sent "Product Bulletin" notification letters to their consignees on 05/24/2013 or 05/30/2013. The letter described the product issue and provided customers with recommended actions. Questions were directed to (512) 873-0033.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LZF
- Quantity affected
- 7,000
- Distribution
- Nationwide Distribution.
- Date initiated
- 2013-05-24
- Date posted
- 2013-06-11
- Date terminated
- 2013-07-29
- Location
- Austin, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD. (K922997) | Via Medical Corp. | 1994-01-11 |