JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
FDA Recall Z-1425-2018 · Posted None
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Recalling FirmCarefusion 2200 Inc
Recall StatusTerminated
Product CodeFSH
Date Initiated2017-02-23
Date Terminated2019-07-09
Product Quantity14,200 units
Reason for Recall
The integrity of the sterile packaging is potentially compromised.
Firm Action
On 2/23/2017, firm notified customers of recall via mailed letter. The letter included a recall response form. Customers were directed to either return the affected product along with the response form or destroy it and return the response form, indicating the product had been destroyed. All affected product will be destroyed.
Root Cause
Package design/selection
Distribution Pattern
Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
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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