Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)

Reason: A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.

Code information: Lot: 00112758, Use by 2018-05-11

Distribution pattern: CA, FL, KY, MO, NM, OK, OR, PA, and TX.