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Terminated

Bacchus brand Trellis Reserve, Peripheral Infusion System, 6.0 Fr Catalog Numbers: BAC TRE 06 100 10, BAC TRE 06 100 20, BAC TRE 06 140 10, BAC TRE 06 140 20

FDA Recall Z-0817-04 · Posted 2004-07-20

Recalling FirmBacchus Vascular Inc
Recall StatusTerminated
Product CodeKRA
Date Initiated2003-11-24
Date Terminated2004-05-06
Product Quantity1260 units

Reason for Recall

The device has the potential for fractures at the distal end during use.

Firm Action

On 11/24/03, all consignees were notified via phone calls and/or on-site visit by the firm''s sales representative, informing them of the affected devices and providing instructions on the recall.

Root Cause

Other

Distribution Pattern

Product was released for distribution to 131 consignees in US. The firm identified 18 foreign distributors that received recall products. The product received nationwide distribution. The firm has also distributed products into international channels through distributors. Countries include: NETHERLANDS, Argentina, ISRAEL, Czech Republic, ARGENTINA, GERMANY, AUSTRIA, SWITZERLAND, IRELAND, HONG KONG, GERMANY, GREECE, Belgium, SOUTH AFRICA, UK, ITALY, UK, and NORWAY There is no known U. S. Government or Canadian distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023514TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH)Bacchus Vascular, Inc. · 2002-12-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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