Unomedical As: Medical Device Recall in 2016 - (Recall #: Z-0358-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

Product Classification:

Class II

Date Initiated: November 7, 2014

Date Posted: November 9, 2016

Recall Number: Z-0358-2017

Event ID: 74242

Reason for Recall:

Tubing detachment

Status: Terminated

Product Quantity: 22,114 units

Code Information:

5048997, 5048998, 5048999, 5052118, 5052332, 5052333, 5052334, 5063721, 5066962, 5066963, 5066964

Distribution Pattern:

Worldwide Distribution - US including CA, IN, PA, and Internationally to Canada, Korea, and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated