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Terminated

BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray

FDA Recall Z-0628-05 · Posted 2005-03-18

Recalling FirmBecton Dickinson Infusion Therapy
Recall StatusTerminated
Product CodeDYB
Date Initiated2005-01-10
Date Terminated2005-04-12
Product Quantity15 units

Reason for Recall

Various procedure trays and kits may have an insufficient seal, thus compromising sterility.

Firm Action

Customers were contacted by telephone and by letters dated 01/10/05.

Root Cause

Other

Distribution Pattern

Domestic distribution: WI. International distribution: Puerto Rico, Virgin Islands. There were no military or VA facilities.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K941428EXACTA PERCUTANEOUS INTRODUCER SHEATHOhmeda Medical · 1994-07-06

Official Source

View FDA Recall →

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

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