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Open, Classified

ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

FDA Recall Z-0017-2025 · Posted 2024-10-18

Recalling FirmSmiths Medical ASD Inc.
Recall StatusOpen, Classified
Product CodeFPA
Date Initiated2024-06-26
Product Quantity2881080 units

Reason for Recall

Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

Firm Action

Smiths Medical issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 06/26/2024 via mail. The notice explained the issue, potential risks, and requested the affected product be quarantined, and the response for returned to initiate the return and replacement process. Distributors were directed to notify their customers. For further inquires: Product complaints or adverse events: [email protected] 1-(866)-216-8806 Additional information or technical assistance 1-(800)-241-4002, option 3 [email protected]

Root Cause

Process control

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081156CADD MEDICATION CASSETTE RESERVOIRSmiths Medical MD, Inc. · 2008-07-18

Official Source

View FDA Recall →

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

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