Recall Z-0215-2018— Terumo Medical Corp

Name: FDA recall Z-0215-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-07

Class II · Terminated

Class II FDA medical device recall by Terumo Medical Corp, initiated 2017-06-07, terminated 2019-04-25. It names one FDA 510(k) clearance: K142183. Product: Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY. Reason: 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..

Recalling firm: Terumo Medical Corp
Classification: Class II
Status: Terminated
Initiated: 2017-06-07
Terminated: 2019-04-25
Firm location: Somerset, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K142183 — GLIDESHEATH SLENDERTerumo Medical Corporation·cleared 2014-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*CS6F10NA, STERILE, Rx ONLY

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.