Terumo Medical Corp: Medical Device Recall in 2017 - (Recall #: Z-0214-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY

Product Classification:

Class II

Date Initiated: June 7, 2017

Date Posted: December 20, 2017

Recall Number: Z-0214-2018

Event ID: 77661

Reason for Recall:

An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected lot population, 0.01% (1 in 10, 000 units). This breach of the sterile barrier may compromise the sterility of the sheath.

Status: Terminated

Product Quantity: N/A

Code Information:

Lot 161104

Distribution Pattern:

Nationwide and Canada

Voluntary or Mandated:

Voluntary: Firm initiated