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Terminated

Portex Custom Pro-Vent Arterial Blood Sampling Kit Catalog Number: G1615

FDA Recall Z-0253-05 · Posted 2004-11-24

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2004-09-09
Date Terminated2012-05-08

Reason for Recall

Sterility of the device is compromised due to packaging defects

Firm Action

Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1. On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952516PRO-VENT, LINE DRAW, PULSATORSmiths Industries Medical Systems, Inc. · 1995-07-14

Official Source

View FDA Recall →

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

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