—#52011

Product

BD 5ml Syringe Luer-Lok Tip Bulk Sterile Convenience Pak Latex Free

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K980987
Affected lot / code info: Lot number 7002604 Ref 309703

Why it was recalled

Small cracks in plastic trays of one lot of BD 5mL Syringe Luer Lok Tip, Bulk Sterile Convenience Paks that may adversely affect tray integrity and steriity.

Root cause (FDA determination)

Other

Action the firm took

Recall communications were sent on April 2, 2007 and May 3, 2007 by UPS second day air to all direct consignees and potential customers.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2007-04-09
Posted by FDA: 2007-05-24
Terminated: 2007-08-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #52011. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.