Z-2446-2008

Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN...

Name: Z-2446-2008 Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN...
Creator: Smith & Nephew Inc
Published: 2008-08-05
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2008-08-05 / Terminated / root cause: packaging

FDA source

Smith & Nephew Inc began a recall of Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116 on 2008-08-05. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2446-2008
Status: Terminated
Initiated: 2008-08-05
Posted: 2008-09-20
Terminated: 2010-05-28
Recalling firm: Smith & Nephew, Inc.
Product: Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116.
Product code: FMF Syringe, Piston
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.
Root cause tag: packaging
FDA root cause: Other
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
Quantity in commerce: 364 units
Distribution: Nationwide Distribution
Product codes and lots: Lot Nos.: 07EQT0003, 07EQT0004, 07EQT0005, 07JQT0003, 07KQT0002, 63207107, 07HM12429, and 07JM15582.

Product code FMF

K041976Class IISmith & Nephew Graft Delivery SystemSmith & Nephew, Inc. / cleared 2004-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)