Precision Delivery Set with Filter, REF: PD06F; and Precision Delivery Set with Trifurcated Luer, REF: PDT05CV2
FDA Recall Z-1100-2023 · Posted 2023-02-07
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Recalling FirmQuest Medical, Inc.
Recall StatusOpen, Classified
Product CodeFPA
Date Initiated2022-12-23
Product Quantity13,900
Reason for Recall
Delivery Sets may have tubing that could become detached that could result in patient infection.
Firm Action
On 12/23/22, the recall notice was distributed. The customer was asked to return affected devices and to call 1-800-627-0226, extension 311, if they had any questions.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the state of MA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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