CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile

FDA device recall Z-0987-2009 · posted 2009-04-20 · Terminated

Recall details

Recalling firm

Smiths Medical MD, Inc.

Reason for recall

Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs Reorder Number 21-7002-24 Lot Numbers 213X18 and 214X18. If a leak occurs in a CADD medication Cassette Reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the Reservoir. Smiths Medical has not received any report of patient injuries due

Action taken

An "Urgent Medical Device Recall" letter was sent via electronic mail to consignees on December 8, 2008. The letter was addressed to Distributors, Clinicians and other Customers. The letter described the problem and affected product and listed the "Advise on Action to be Taken by the User". Smiths Medical MD, Inc. requested the user to complete and return the "Urgent Medical Device Recall Confirmation Fax Return Form" and fax to the firm at 1-651-628-7485 or e-mail to info.md@smiths-medical.com (in US) or international.customer.service@smiths-medical.com (outside US). Direct questions to the Smiths Medical MD, Inc. Customer Service Department at 1-800-426-2448, Option 1.

Root cause

Process control

Status

Terminated

Product code

FPA

Quantity affected

17,868 cassettes (1,489 boxes 12 cassettes/box)

Distribution

Worldwide Distribution USA (state of PA) and countries of El Salvador, Australia, France, Finland, Sweden, and Germany.

Date initiated

2008-12-09

Date posted

2009-04-20

Date terminated

2012-06-07

Location

Saint Paul, MN

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