Bd Insulin Syringe

• • Terminated Z-0183-2018 FDA Class II ·initiated 25 May 2017

  Product mislabel. Lot 6291768 of the BD Insulin Syringes with the BD Ultra-Fine needle mL 12.7mm 30G, Cat (Ref) 328466, was found to have some polybags in the lot incorrectly labeled as BD Ultra-Fine needle mL 8mm 31G, Cat (Ref) 328468. The shelf carton and case carton are correctly labeled as BD Ultra-Fine needle mL 12.7mm 30G.

• • Terminated Z-0174-2012 FDA Unclassified (pre-2012) ·initiated 15 Jun 2011 ·via K024112, on the same 510(k)

  Experiment labels may be on shelf cartons of 1.0ml 28G x 1/2 blister packaged insulin syringes.

• • Terminated Z-1226-2007 FDA Unclassified (pre-2012) ·initiated 21 Jun 2007 ·via K024112, on the same 510(k)

  Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K024112 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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