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Terminated

Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic.

FDA Recall Z-0098-04 · Posted 2003-11-06

Recalling FirmBard Access Systems, Inc
Recall StatusTerminated
Product CodeFMI
Date Initiated2003-09-23
Date Terminated2004-03-18
Product Quantity106,500 units

Reason for Recall

Sterility of product is compromised by open seals in packaging.

Firm Action

Recall letters were sent to US customers on September 23, 2003. International customers were sent communication on September 24, 2003.

Root Cause

Other

Distribution Pattern

Nationwide. Foreign distribution to Australia, Brazil, Canada, China, Hong Kong, India, Japan, Malaysia, Singapore, Taiwan, Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K863606BUTTERFLY NON-CORING NEEDLE SETCormed, Inc., Sub. C.R.Bard, Inc. · 1986-12-18

Official Source

View FDA Recall →

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

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