Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116.
FDA Recall Z-2446-2008 · Posted 2008-09-20
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Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeFMF
Date Initiated2008-08-05
Date Terminated2010-05-28
Product Quantity364 units
Reason for Recall
Product contained a syringe whose package seal integrity can be adversely affected when the product is exposed to low atmospheric pressure. This may occur during shipping.
Firm Action
Prior to the dissemination of the official notices, the firm notified personnel at our field offices of the BD syringe recall and advised that a subsequent recall of our Caption devices would follow. High volume users were contacted via phone on July 30th and the 31st and personnel at all affected field offices were notified via email on July 30, 2008 with an Urgent Medical Device Recall Letter. The firm requedsted that usere immediately cease distribution, examin the stock on hand and the stock of the accounts that have been suppplied and remove any affected ecices from all inventory. A verification notification was included with letter
Root Cause
Other
Distribution Pattern
Nationwide Distribution
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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