Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set, one Ventricular Drainage System, one INS-HITH Cranial Access Kit, one Sodium Chloride 10 ml, and one Suture 2-0 silk.
FDA Recall Z-1097-04 · Posted 2004-07-20
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Recalling FirmIntegra Life Sciences Corp.
Recall StatusTerminated
Product CodeHCA
Date Initiated2003-03-19
Date Terminated2004-08-05
Product Quantity6 kits
Reason for Recall
The outer labeling of the convenience kit indicates that an additional bottle of Sodium Chloride (saline) solution is included in the Custom Kit 31176; however, an additional bottle of 1% Xylocaine was included in the Custom Kit.
Firm Action
The recalling firm telephoned the customer on 3/19/03. The recalling firm followed up with a recall letter on 3/24/03.
Root Cause
Other
Distribution Pattern
The product was shipped to one hospital in NY.
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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