LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code: ER320) and assorted Flex Trays(Convenience Kits), containing ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers.
FDA Recall Z-1055-04 · Posted 2004-07-20
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Recalling FirmEthicon Endo-Surgery
Recall StatusTerminated
Product CodeGDO
Date Initiated2004-06-07
Date Terminated2008-10-29
Product Quantity120,4015
Reason for Recall
This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubular structures.
Firm Action
The firm contacted their customers via letter on June 7, 2004. The suspect product and Flex Tray kits will be returned and destroyed.
Root Cause
Other
Distribution Pattern
The product was shipped to hospitals and distributors nationwide and worldwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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