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Terminated

Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates. For distribution to Germany only.

FDA Recall Z-1085-03 · Posted 2003-08-06

Recalling FirmBallard Medical Products
Recall StatusTerminated
Product CodeBSY
Date Initiated2003-06-13
Date Terminated2003-11-24
Product Quantity425 units

Reason for Recall

Incorrect plug was included in the multi access catheter pkg. When inserted in the 'Y' it may disengage, allowing a leak of ventilator gases.

Firm Action

All consignees were notified by letter on 06/13/2003.

Root Cause

Other

Distribution Pattern

Nationwide and to Belgium, Canada, Colombia, Germany, Japan, Norway, South Africa, Sweden, Switzerland, Turkey, United Kingdom.

Official Source

View FDA Recall →

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

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