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Terminated

7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton.

FDA Recall Z-0346-06 · Posted 2006-01-06

Recalling FirmB. Braun Medical, Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2005-09-01
Date Terminated2006-01-05
Product Quantity8000 units

Reason for Recall

Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).

Firm Action

The recalling firm telephoned their customers on 91/05 & 9/14/05 to inform them of the problem.

Root Cause

Other

Distribution Pattern

The product was shipped to two consignees that repack the product into their own kits.

Official Source

View FDA Recall →

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

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