—#50186

Product

BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle 1 ml 29g 1/2'' (0.33mm x 13 mm) Re-Order No. 305282 U-100 insulin Lot 6073436

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K023752
Affected lot / code info: Lot # 6073436 Ref (Reorder number) 305282)

Why it was recalled

The needle becomes detached from the hub/syringe

Root cause (FDA determination)

Other

Action the firm took

Recall notification letters were sent via UPS second day air on January 27, 2007. Distributors were asked to provide end user contact information to recalling firm.

Recalling firm

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

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2007-01-27
Posted by FDA: 2007-03-03
Terminated: 2007-07-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50186. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.