Acuject Variable Injection Needle
FDA Recall Z-2089-2019 · Posted None
Recalling FirmWilson-Cook Medical Inc.
Recall StatusTerminated
Product CodeFBK
Date Initiated2019-06-14
Date Terminated2021-04-02
Product Quantity24
Reason for Recall
Potential for occluded injection needles.
Firm Action
Wilson-Cook Medical notified their customer on about 06/14/2019 via "URGENT: MEDICAL DEVICE RECALL" letter. The letter instructed customers to examine inventory for affected devices, quarantine any affected devices, notify customers if the product has been further distributed, and return affected devices to Cook China as soon as possible. The customer was also instructed to complete the provided Recall Return Response form and send it to Cook China.
Root Cause
Employee error
Distribution Pattern
Distributed to China
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.