FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: Caption Disposable Platelet Concentrator Kit, Ref 71178202, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116
- Recall number
- Z-2447-2008
- Recalling firm
- Smith & Nephew Inc
- Product
- Caption Disposable Platelet Concentrator Kit, Ref 71178202, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116
- Status
- Terminated
- Initiated
- 2008-08-05
- Posted
- 2008-09-20
- Terminated
- 2010-05-28
- Reason
- 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
- 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
- 568 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot Nos.: 08EQT0001, 08DQT0001, 08CQT0003, 08BQT0002, and 08AQT0003
- 510(k) numbers
- ["K041976"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28