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Terminated

STA-Compact Hemostasis System with Cap piercing capability.

FDA Recall Z-0899-03 · Posted 2003-05-29

Recalling FirmDiagnostica Stago, Inc.
Recall StatusTerminated
Product CodeGKP
Date Initiated2003-03-05
Date Terminated2003-09-09
Product Quantity79

Reason for Recall

With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.

Firm Action

The firm sent out letters on March 5, 2003 to their customers alerting them to the problem and providing further guidance on how to prevent the problem. The firm will be sending out to the customers a protective device to attach to the needle assembly as soon as possible

Root Cause

Other

Distribution Pattern

The product was shipped to 47 hospitals throughout the nation. Other units were shipped to the firm sales representatives.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZERAmerican Bioproducts Co. · 1998-11-12K961579STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZERAmerican Bioproducts Co. · 1996-07-10

Official Source

View FDA Recall →

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

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