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Terminated

Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for Neonates.

FDA Recall Z-1079-03 · Posted 2003-08-06

Recalling FirmBallard Medical Products
Recall StatusTerminated
Product CodeBSY
Date Initiated2003-06-13
Date Terminated2003-11-24
Product Quantity1565 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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K872621TRACH CARE CATHETERBallard Medical Products · 1987-09-15

Official Source

View FDA Recall →

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

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