FDA recall Z-2645-2017

Product

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 for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2016-12-15

Report date

2017-07-12

Termination date

2018-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2645-2017