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Terminated

Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313

FDA Recall Z-1078-04 · Posted 2004-07-20

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeFMI
Date Initiated2004-06-29
Date Terminated2006-05-02
Product Quantity180 CASES (400/CS)

Reason for Recall

Sterility of product is not assured

Firm Action

Smiths Medical notified consignees by telephone on June 29, 2004. The consignees were asked to immediately quarantine their stock . The Dealers and direct customers were contacted via letter delivered by Federal Express on July 2, 2004.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011925HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PRO SYRINGE & NEEDLE WITH NEEDLE PROTECTIOSims Portex, Inc. · 2001-07-12

Official Source

View FDA Recall →

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

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