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Terminated

Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4

FDA Recall Z-0104-06 · Posted 2005-10-28

Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeLJS
Date Initiated2005-09-15
Date Terminated2005-11-22
Product Quantity88 units

Reason for Recall

The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F

Firm Action

On 9/15/05, the recalling firm telephoned the two distributors to inform them of the problem and the need to return the product.

Root Cause

Other

Distribution Pattern

The products were shipped to distributors in OH and MO.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003682MEDCOMP Z-CATHMedical Components, Inc. · 2001-01-26

Official Source

View FDA Recall →

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

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