—#72817

Product

Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each, Sterile, Smith & Nephew, Inc. Memphis, TN 38116.

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K041976
Affected lot / code info: Lot Nos.: 07EQT0003, 07EQT0004, 07EQT0005, 07JQT0003, 07KQT0002, 63207107, 07HM12429, and 07JM15582.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2008-08-05
Posted by FDA: 2008-09-20
Terminated: 2010-05-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.