Recalls / —

—#53537

Product

ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin.

FDA product code

FMI — Needle, Hypodermic, Single Lumen

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K024112

Affected lot / code info

Catalog number 326743, Batch number 6297350

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

Urgent Product Recall notifications were sent on 6/21/07 asking them to discontinue use of product, remove from inventory and complete Tracking Verification form.

Recalling firm

Firm

Becton Dickinson & Company

Address

1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2007-06-21

Posted by FDA

2007-09-20

Terminated

2008-06-03

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #53537. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.